Trial Outcomes & Findings for Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (NCT NCT00883233)
NCT ID: NCT00883233
Last Updated: 2021-02-18
Results Overview
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit \[None=0, Mild=1, Moderate=2 and Severe=3\]. In consequence, it ranges from 0 \[better outcome\] to 12 \[worse outcome\]and was calculated for each study visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
Week 4
Results posted on
2021-02-18
Participant Flow
Recruitment period: 23 APR 2009 to 09 SEP 2009 in three private practice Canadian centres. Two centers used a central IRB, and the other used a local IRB.
Participant milestones
| Measure |
Adapalene-BPO Gel 3h
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel EoD
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel Cetaphil
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
|
Adapalene-BPO Gel StD
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
29
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene-BPO Gel 3h
n=32 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel EoD
n=32 Participants
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel Cetaphil
n=29 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
|
Adapalene-BPO Gel StD
n=30 Participants
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
20.4 years
STANDARD_DEVIATION 6.39 • n=7 Participants
|
20.9 years
STANDARD_DEVIATION 6.83 • n=5 Participants
|
20.8 years
STANDARD_DEVIATION 6.31 • n=4 Participants
|
20.6 years
STANDARD_DEVIATION 6.43 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
29 participants
n=5 Participants
|
30 participants
n=4 Participants
|
123 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 4Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit \[None=0, Mild=1, Moderate=2 and Severe=3\]. In consequence, it ranges from 0 \[better outcome\] to 12 \[worse outcome\]and was calculated for each study visit.
Outcome measures
| Measure |
Adapalene-BPO Gel 3h
n=32 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel EoD
n=32 Participants
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel Cetaphil
n=29 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
|
Adapalene-BPO Gel StD
n=30 Participants
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
|
|---|---|---|---|---|
|
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
|
4.23 Scores on a scale
Standard Deviation 2.04
|
3.06 Scores on a scale
Standard Deviation 1.92
|
3.25 Scores on a scale
Standard Deviation 2.05
|
4.13 Scores on a scale
Standard Deviation 2.45
|
Adverse Events
Adapalene-BPO Gel 3h
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Adapalene-BPO Gel EoD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Adapalene-BPO Gel Cetaphil
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Adapalene-BPO Gel StD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adapalene-BPO Gel 3h
n=32 participants at risk
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel EoD
n=32 participants at risk
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
|
Adapalene-BPO Gel Cetaphil
n=29 participants at risk
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
|
Adapalene-BPO Gel StD
n=30 participants at risk
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
erythema
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
headache
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
nasopharyngitis
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
10.3%
3/29 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
sunburn
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.00%
0/32 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
6.7%
2/30 • Number of events 2 • 12 weeks
|
|
Infections and infestations
impetigo
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
upper track respiratory infection
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
skin burning sensation
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
herpes simplex
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
tooth abscess
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
skin oedema
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Injury, poisoning and procedural complications
mouth injury
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
face oedema
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/32 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Injury, poisoning and procedural complications
arthropod bite
|
0.00%
0/32 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
0.00%
0/32 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
pharyngitis
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/32 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
epicondylitis
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER