Trial Outcomes & Findings for Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris. (NCT NCT02073461)
NCT ID: NCT02073461
Last Updated: 2017-03-28
Results Overview
Median percent reductions from Baseline in total lesion count (ITT-LOCF)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
236 participants
Primary outcome timeframe
Baseline - Week 12
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
CD1579 2.5%
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
Vehicle
Vehicle
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
79
|
|
Overall Study
COMPLETED
|
75
|
77
|
78
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Baseline characteristics by cohort
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
21.0 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
21.4 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
79 participants
n=5 Participants
|
78 participants
n=7 Participants
|
79 participants
n=5 Participants
|
236 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 12Median percent reductions from Baseline in total lesion count (ITT-LOCF)
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=78 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Percent Changes From Baseline in Total Lesion Counts
|
58.3 percent change
Interval -243.7 to 100.0
|
65.9 percent change
Interval -41.0 to 100.0
|
25.5 percent change
Interval -180.7 to 88.9
|
SECONDARY outcome
Timeframe: up to 12 weeksAdverse events which were observed in 5% or more patients with either group are listed.
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Percent of Subjects With Adverse Events
% of subjects with AEs
|
43.0 percentage of participants
|
39.7 percentage of participants
|
32.9 percentage of participants
|
|
Percent of Subjects With Adverse Events
Nasopharyngitis
|
12.7 percentage of participants
|
14.1 percentage of participants
|
13.9 percentage of participants
|
|
Percent of Subjects With Adverse Events
Headache
|
10.1 percentage of participants
|
1.3 percentage of participants
|
8.9 percentage of participants
|
|
Percent of Subjects With Adverse Events
Dysmenorrhea
|
6.3 percentage of participants
|
3.8 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Local Tolerability (Erythema)
Mild
|
12 participants
|
18 participants
|
5 participants
|
|
Local Tolerability (Erythema)
Moderate
|
3 participants
|
3 participants
|
0 participants
|
|
Local Tolerability (Erythema)
Severe
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Local Tolerability (Scaling)
Moderate
|
4 participants
|
7 participants
|
1 participants
|
|
Local Tolerability (Scaling)
Mild
|
15 participants
|
25 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Local Tolerability (Dryness)
Mild
|
20 participants
|
33 participants
|
10 participants
|
|
Local Tolerability (Dryness)
Moderate
|
2 participants
|
6 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Local Tolerability (Pruritus)
Mild
|
20 participants
|
13 participants
|
6 participants
|
|
Local Tolerability (Pruritus)
Moderate
|
6 participants
|
7 participants
|
1 participants
|
|
Local Tolerability (Pruritus)
Severe
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksHighest severity of local tolerability scores worse than Baseline
Outcome measures
| Measure |
CD1579 2.5%
n=79 Participants
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 Participants
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 Participants
Vehicle
Vehicle
|
|---|---|---|---|
|
Local Tolerability (Stinging/Burning)
Mild
|
19 participants
|
29 participants
|
4 participants
|
|
Local Tolerability (Stinging/Burning)
Moderate
|
6 participants
|
7 participants
|
1 participants
|
Adverse Events
CD1579 2.5%
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
CD1579 5%
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD1579 2.5%
n=79 participants at risk
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 participants at risk
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 participants at risk
Vehicle
Vehicle
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • 12 weeks
|
Other adverse events
| Measure |
CD1579 2.5%
n=79 participants at risk
Benzoyl Peroxide 2.5%
CD1579 2.5%
|
CD1579 5%
n=78 participants at risk
Benzoyl Peroxide 5%
CD1579 5%
|
Vehicle
n=79 participants at risk
Vehicle
Vehicle
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Eye disorders
Erythema of eyelid
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Immune system disorders
Seasonal allergy
|
2.5%
2/79 • Number of events 2 • 12 weeks
|
2.6%
2/78 • Number of events 2 • 12 weeks
|
2.5%
2/79 • Number of events 2 • 12 weeks
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
10/79 • Number of events 11 • 12 weeks
|
14.1%
11/78 • Number of events 12 • 12 weeks
|
13.9%
11/79 • Number of events 12 • 12 weeks
|
|
Infections and infestations
Oral herpes
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
2.6%
2/78 • Number of events 2 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Otitis externa
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Tinea pedis
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Laryngitis
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Investigations
Protein urine present
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Nervous system disorders
Headache
|
10.1%
8/79 • Number of events 11 • 12 weeks
|
1.3%
1/78 • Number of events 7 • 12 weeks
|
8.9%
7/79 • Number of events 13 • 12 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.3%
5/79 • Number of events 8 • 12 weeks
|
3.8%
3/78 • Number of events 4 • 12 weeks
|
3.8%
3/79 • Number of events 4 • 12 weeks
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.5%
2/79 • Number of events 2 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.8%
3/79 • Number of events 3 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
2.6%
2/78 • Number of events 2 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
2.6%
2/78 • Number of events 2 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/79 • 12 weeks
|
0.00%
0/78 • 12 weeks
|
1.3%
1/79 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/79 • 12 weeks
|
1.3%
1/78 • Number of events 1 • 12 weeks
|
0.00%
0/79 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place