Trial Outcomes & Findings for Photocil (Topical) for the Treatment of Atopic Dermatitis (NCT NCT01992172)
NCT ID: NCT01992172
Last Updated: 2016-03-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
30 days from baseline
Results posted on
2016-03-25
Participant Flow
Participant milestones
| Measure |
Photocil for Atopic Dermatitis
Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis
|
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
0
|
|
Overall Study
COMPLETED
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photocil (Topical) for the Treatment of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Photocil for Atopic Dermatitis
n=7 Participants
Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis
|
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.3 Years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
—
|
32.3 Years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days from baselineOutcome measures
| Measure |
Photocil for Atopic Dermatitis
n=7 Participants
Active Drug - Photocil for Atopic Dermatitis
Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis
|
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
|---|---|---|
|
Number of Pruritus Events in Last 30 Days
Baseline
|
7.4 Events
Standard Deviation 2.9
|
—
|
|
Number of Pruritus Events in Last 30 Days
90 Day
|
1.9 Events
Standard Deviation 1.5
|
—
|
Adverse Events
Photocil for Atopic Dermatitis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo - Sunscreen (SPF 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60