Trial Outcomes & Findings for Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris (NCT NCT02651220)
NCT ID: NCT02651220
Last Updated: 2020-06-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1001 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-06-23
Participant Flow
1001 patients were randomized, 24 did not receive any study medication.
Participant milestones
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
337
|
335
|
329
|
|
Overall Study
COMPLETED
|
314
|
308
|
300
|
|
Overall Study
NOT COMPLETED
|
23
|
27
|
29
|
Reasons for withdrawal
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
14
|
|
Overall Study
Non-Compliance with Study Drug
|
4
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
8
|
|
Overall Study
Miscellaneous
|
4
|
1
|
2
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
1
|
1
|
Baseline Characteristics
Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=332 Participants
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=323 Participants
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=322 Participants
Placebo gel: vehicle used as placebo
|
Total
n=977 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
614 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
363 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
139 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
421 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
548 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Using the Per Protocol Population
Outcome measures
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=285 Participants
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=281 Participants
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=277 Participants
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.
|
-74.2 percentage of change from baseline
Standard Deviation 25.0
|
-73.0 percentage of change from baseline
Standard Deviation 27.8
|
-30.6 percentage of change from baseline
Standard Deviation 32.7
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Using the Per Protocol Population
Outcome measures
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=285 Participants
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=281 Participants
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=277 Participants
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.
|
-65.4 percentage of change from baseline
Standard Deviation 25.7
|
-64.5 percentage of change from baseline
Standard Deviation 26.0
|
-25.5 percentage of change from baseline
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Using the Modified Intent to Treat Population
The Investigator's Global Assessment had to show a score of 0 (clear) or 1 (almost clear) to be considered a "Clinical Success". 0= Clear skin with no inflammatory or non inflammatory lesions. 1. Almost clear, rare non-inflammatory lesions with no more than one small inflammatory lesion. 2. Mild severity; greater than Grade 1; some non inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions). 3. Moderate severity; greater than Grade 2; up to many non inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion. 4. Severe; greater than Grade 3, up to many non inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions. 5. Very severe, greater than Grade 4
Outcome measures
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=331 Participants
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=321 Participants
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=321 Participants
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Percentage of Patients With a Clinical Response of "Clinical Success" Using the Investigator's Global Assessment (IGA) at Week 12
|
112 Participants
|
106 Participants
|
15 Participants
|
Adverse Events
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Epiduo® Forte Gel 0.3%/2.5% w/w
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Vehicle Topical Gel
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=332 participants at risk
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=323 participants at risk
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=322 participants at risk
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Up to at least 3 months
|
Other adverse events
| Measure |
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
n=332 participants at risk
Generic: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Epiduo® Forte Gel 0.3%/2.5% w/w
n=323 participants at risk
Reference: Epiduo® Forte Gel: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
|
Vehicle Topical Gel
n=322 participants at risk
Placebo gel: vehicle used as placebo
|
|---|---|---|---|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
General disorders
Application site dryness
|
0.00%
0/332 • Up to at least 3 months
|
1.5%
5/323 • Number of events 8 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
General disorders
Application site erythema
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
General disorders
Application site hypersensitivity
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
General disorders
Application site irritation
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
General disorders
Application site pain
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
1.5%
5/323 • Number of events 6 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
General disorders
Application site pruritus
|
0.00%
0/332 • Up to at least 3 months
|
0.62%
2/323 • Number of events 3 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
General disorders
Pain
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
General disorders
Pyrexia
|
0.60%
2/332 • Number of events 2 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Immune system disorders
Food allergy
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Immune system disorders
Multiple allergies
|
0.30%
1/332 • Number of events 2 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Infections and infestations
Helicobacter infection
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Infections and infestations
Influenza
|
1.2%
4/332 • Number of events 4 • Up to at least 3 months
|
3.1%
10/323 • Number of events 10 • Up to at least 3 months
|
1.9%
6/322 • Number of events 6 • Up to at least 3 months
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
7/332 • Number of events 7 • Up to at least 3 months
|
2.5%
8/323 • Number of events 8 • Up to at least 3 months
|
1.6%
5/322 • Number of events 5 • Up to at least 3 months
|
|
Infections and infestations
Sinusitis
|
0.60%
2/332 • Number of events 2 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Infections and infestations
Vaginitis bacterial
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Musculoskeletal and connective tissue disorders
Musckuloskeletal pain
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Nervous system disorders
Heachache
|
1.2%
4/332 • Number of events 4 • Up to at least 3 months
|
0.62%
2/323 • Number of events 3 • Up to at least 3 months
|
0.93%
3/322 • Number of events 4 • Up to at least 3 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.60%
2/332 • Number of events 2 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.60%
2/332 • Number of events 2 • Up to at least 3 months
|
1.2%
4/323 • Number of events 4 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.62%
2/323 • Number of events 2 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/332 • Up to at least 3 months
|
0.31%
1/323 • Number of events 1 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.30%
1/332 • Number of events 1 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.00%
0/322 • Up to at least 3 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/332 • Up to at least 3 months
|
0.00%
0/323 • Up to at least 3 months
|
0.31%
1/322 • Number of events 1 • Up to at least 3 months
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER