Trial Outcomes & Findings for Assessment of the Human Systemic Absorption of Sunscreen Ingredients (NCT NCT03582215)
NCT ID: NCT03582215
Last Updated: 2020-04-21
Results Overview
Maximum concentration (observed peak drug concentration) (Cmax)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2
Results posted on
2020-04-21
Participant Flow
Equal allocation of men and women for each treatment arm.
Participant milestones
| Measure |
Part 1: Cream
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
12
|
12
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Part 1: Cream
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
Baseline Characteristics
Assessment of the Human Systemic Absorption of Sunscreen Ingredients
Baseline characteristics by cohort
| Measure |
Part 2: Pump Spray
n=12 Participants
Part 2: Pump Spray
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Total
n=72 Participants
Total of all reporting groups
|
Part 1: Cream
n=6 Participants
Part 1: Cream
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=6 Participants
Part 1: Lotion
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=6 Participants
Part 1: Spray 1
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=6 Participants
Part 1: Spray 2
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
n=12 Participants
Part 2: Lotion
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Part 2: Sunscreen Product #1, 2, 3 or 4: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
n=12 Participants
Part 2: Aerosol Spray
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
n=12 Participants
Part 2: Nonaerosol Spray
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
37.6 years
STANDARD_DEVIATION 12.4 • n=42 Participants
|
31.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
41.4 years
STANDARD_DEVIATION 13.4 • n=8 Participants
|
39.2 years
STANDARD_DEVIATION 12.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=24 Participants
|
65 Participants
n=42 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=24 Participants
|
72 participants
n=42 Participants
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=8 Participants
|
12 participants
n=8 Participants
|
|
Body mass index (kg/m2)
|
26.0 kg/m2
STANDARD_DEVIATION 3.3 • n=24 Participants
|
25.7 kg/m2
STANDARD_DEVIATION 2.9 • n=42 Participants
|
26.7 kg/m2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 2.5 • n=7 Participants
|
24.1 kg/m2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
24.0 kg/m2
STANDARD_DEVIATION 3.0 • n=4 Participants
|
26.2 kg/m2
STANDARD_DEVIATION 2.2 • n=21 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 3.7 • n=8 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 2.4 • n=8 Participants
|
|
Fitzpatrick Skin Type
I
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Fitzpatrick Skin Type
II
|
1 participants
n=24 Participants
|
10 participants
n=42 Participants
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Fitzpatrick Skin Type
III
|
9 participants
n=24 Participants
|
35 participants
n=42 Participants
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
10 participants
n=8 Participants
|
6 participants
n=8 Participants
|
|
Fitzpatrick Skin Type
IV
|
2 participants
n=24 Participants
|
13 participants
n=42 Participants
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
|
Fitzpatrick Skin Type
V
|
0 participants
n=24 Participants
|
8 participants
n=42 Participants
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 participants
n=24 Participants
|
6 participants
n=42 Participants
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Weight (kg)
|
75.5 kg
STANDARD_DEVIATION 12.9 • n=24 Participants
|
74.2 kg
STANDARD_DEVIATION 12.1 • n=42 Participants
|
77.6 kg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
73.2 kg
STANDARD_DEVIATION 17.3 • n=7 Participants
|
70.9 kg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
69.1 kg
STANDARD_DEVIATION 12.5 • n=4 Participants
|
76.3 kg
STANDARD_DEVIATION 10.8 • n=21 Participants
|
76.0 kg
STANDARD_DEVIATION 15.6 • n=8 Participants
|
72.0 kg
STANDARD_DEVIATION 8.9 • n=8 Participants
|
|
Height (cm)
|
170.2 cm
STANDARD_DEVIATION 11.1 • n=24 Participants
|
169.8 cm
STANDARD_DEVIATION 10.0 • n=42 Participants
|
170.7 cm
STANDARD_DEVIATION 9.9 • n=5 Participants
|
168.4 cm
STANDARD_DEVIATION 15.5 • n=7 Participants
|
70.9 cm
STANDARD_DEVIATION 9.9 • n=5 Participants
|
171.7 cm
STANDARD_DEVIATION 6.0 • n=4 Participants
|
170.3 cm
STANDARD_DEVIATION 9.7 • n=21 Participants
|
171.0 cm
STANDARD_DEVIATION 11.0 • n=8 Participants
|
167.0 cm
STANDARD_DEVIATION 9.3 • n=8 Participants
|
|
Body surface area (m^2)
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=24 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=42 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.3 • n=7 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=21 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=8 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=8 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=6 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=6 Participants
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=6 Participants
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
n=12 Participants
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
n=12 Participants
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
n=12 Participants
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
n=12 Participants
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Avobenzone Maximum Concentration
|
1.8 ng/mL
Geometric Coefficient of Variation 32
|
4.3 ng/mL
Geometric Coefficient of Variation 46
|
4.0 ng/mL
Geometric Coefficient of Variation 61
|
3.4 ng/mL
Geometric Coefficient of Variation 77
|
7.1 ng/mL
Geometric Coefficient of Variation 74
|
3.5 ng/mL
Geometric Coefficient of Variation 71
|
3.5 ng/mL
Geometric Coefficient of Variation 73
|
3.3 ng/mL
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream and for Part 2, nonaerosol spray and pump spray products did not contain oxybenzone and were excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=6 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=6 Participants
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=12 Participants
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
n=12 Participants
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Oxybenzone Maximum Concentration
|
169.3 ng/mL
Geometric Coefficient of Variation 45
|
209.6 ng/mL
Geometric Coefficient of Variation 67
|
194.9 ng/mL
Geometric Coefficient of Variation 52
|
258.1 ng/mL
Geometric Coefficient of Variation 53
|
180.1 ng/mL
Geometric Coefficient of Variation 57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 2, pump spray product did not contain octocrylene and was excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=6 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=6 Participants
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=6 Participants
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
n=12 Participants
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
n=12 Participants
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
n=12 Participants
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Octocrylene Maximum Concentration
|
5.7 ng/mL
Geometric Coefficient of Variation 47
|
5.7 ng/mL
Geometric Coefficient of Variation 66
|
2.9 ng/mL
Geometric Coefficient of Variation 102
|
7.8 ng/mL
Geometric Coefficient of Variation 113
|
7.8 ng/mL
Geometric Coefficient of Variation 87
|
6.6 ng/mL
Geometric Coefficient of Variation 78
|
6.6 ng/mL
Geometric Coefficient of Variation 104
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, lotion, spray 1, and spray 2 and for Part 2, lotion, aerosol spray, nonaerosol spray, and pump spray did not contain ecamsule and were excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Ecamsule Maximum Concentration
|
1.5 ng/mL
Geometric Coefficient of Variation 166
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain homosalate and were excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=12 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=12 Participants
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=12 Participants
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Homosalate Maximum Concentration
|
40.3 ng/mL
Geometric Coefficient of Variation 74
|
23.1 ng/mL
Geometric Coefficient of Variation 68
|
17.9 ng/mL
Geometric Coefficient of Variation 62
|
13.9 ng/mL
Geometric Coefficient of Variation 70
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain octisalate and were excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=6 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=12 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=12 Participants
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=12 Participants
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Octisalate Maximum Concentration
|
10.0 ng/mL
Geometric Coefficient of Variation 46
|
5.1 ng/mL
Geometric Coefficient of Variation 82
|
5.8 ng/mL
Geometric Coefficient of Variation 77
|
4.6 ng/mL
Geometric Coefficient of Variation 98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2Population: All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, octinoxate was not analyzed for cream, lotion, spray 1, and spray 2 and all products were excluded from the analysis. For Part 2, lotion and aerosol spray did not contain octinoxate and were excluded from the analysis.
Maximum concentration (observed peak drug concentration) (Cmax)
Outcome measures
| Measure |
Part 1: Cream
n=12 Participants
Part 1: Cream:
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=12 Participants
Part 1: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
Part 1: Spray 1:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
Part 1: Spray 2:
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
Part 2: Lotion:
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2.
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
Part 2: Aerosol Spray:
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
Part 2: Nonaerosol Spray:
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
Part 2: Pump Spray:
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Octinoxate Maximum Concentration
|
7.9 ng/mL
Geometric Coefficient of Variation 87
|
5.2 ng/mL
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Cream
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Lotion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Spray 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Spray 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Lotion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2: Aerosol Spray
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: Nonaerosol Spray
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2: Pump Spray
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Cream
n=6 participants at risk
Part 1: Cream
Ingredients: 2% Avobenzone; 10% Octocrylene; 2% Ecamsule
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Lotion
n=6 participants at risk
Part 1: Lotion
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 1
n=6 participants at risk
Part 1: Spray 1
Ingredients: 3% Avobenzone; 6% Oxybenzone; 2.35% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 1: Spray 2
n=6 participants at risk
Part 1: Spray 2
Ingredients: 3% Avobenzone; 5% Oxybenzone; 10% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
|
Part 2: Lotion
n=12 participants at risk
Part 2: Lotion
Ingredients: 3% Avobenzone; 4% Oxybenzone; 6% Octocrylene
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Aerosol Spray
n=12 participants at risk
Part 2: Aerosol Spray
Ingredients: 3% Avobenzone; 6% Oxybenzone; 10% Octocrylene; 15% Homosalate; 5% Octisalate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Nonaerosol Spray
n=12 participants at risk
Part 2: Nonaerosol Spray
Ingredients: 3% Avobenzone; 10% Octocrylene; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
Part 2: Pump Spray
n=12 participants at risk
Part 2: Pump Spray
Ingredients: 3% Avobenzone; 10% Homosalate; 5% Octisalate; 7.5% Octinoxate
Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abodinal Pain
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Gastrointestinal disorders
Chapped lips
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Eye disorders
Eye burning
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 4 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Fatigue
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Gastrointestinal disorders
Lip swelling
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Milia
|
16.7%
1/6 • Number of events 4 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 4 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
1/6 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
50.0%
6/12 • Number of events 7 • 7 days for part 1; 21 days for part 2
MedDRA
|
41.7%
5/12 • Number of events 11 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 7 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
25.0%
3/12 • Number of events 5 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Burning sensation
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
16.7%
2/12 • Number of events 4 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 2 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Tenderness
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
|
General disorders
Vessel punctue site swelling
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/6 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
8.3%
1/12 • Number of events 1 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
0.00%
0/12 • 7 days for part 1; 21 days for part 2
MedDRA
|
Additional Information
David Strauss, MD, PhD
U.S. Food and Drug Administration
Phone: 301-796-6323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place