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Trial record 35 of 142 for:    acne AND erythema

Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris (FREE)

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ClinicalTrials.gov Identifier: NCT00883233
Recruitment Status : Completed
First Posted : April 17, 2009
Results First Posted : December 8, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Adapalene BPO Gel standard daily overnight application
Drug: Adapalene-BPO 3-hour daily application before bedtime
Drug: Adapalene-BPO Gel every other day application
Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Enrollment 123
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Hide Arm/Group Description 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 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 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 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Period Title: Overall Study
Started 32 32 29 30
Completed 27 28 25 25
Not Completed 5 4 4 5
Arm/Group Title Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD Total
Hide Arm/Group Description 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 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 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 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week Total of all reporting groups
Overall Number of Baseline Participants 32 32 29 30 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 29 participants 30 participants 123 participants
<=18 years
15
  46.9%
15
  46.9%
13
  44.8%
14
  46.7%
57
  46.3%
Between 18 and 65 years
17
  53.1%
17
  53.1%
16
  55.2%
16
  53.3%
66
  53.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 29 participants 30 participants 123 participants
20.2  (6.5) 20.4  (6.39) 20.9  (6.83) 20.8  (6.31) 20.6  (6.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 29 participants 30 participants 123 participants
Female
20
  62.5%
19
  59.4%
16
  55.2%
16
  53.3%
71
  57.7%
Male
12
  37.5%
13
  40.6%
13
  44.8%
14
  46.7%
52
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 32 participants 32 participants 29 participants 30 participants 123 participants
32 32 29 30 123
1.Primary Outcome
Title Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Hide Description 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Hide Arm/Group Description:
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 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 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 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Overall Number of Participants Analyzed 32 32 29 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
4.23  (2.04) 3.06  (1.92) 3.25  (2.05) 4.13  (2.45)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Hide Arm/Group Description 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 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 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 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
All-Cause Mortality
Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/32 (0.00%)      0/29 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Adapalene-BPO Gel 3h Adapalene-BPO Gel EoD Adapalene-BPO Gel Cetaphil Adapalene-BPO Gel StD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/32 (25.00%)      5/32 (15.63%)      8/29 (27.59%)      6/30 (20.00%)    
Gastrointestinal disorders         
abdominal pain   0/32 (0.00%)  0 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0
General disorders         
face oedema   1/32 (3.13%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations         
nasopharyngitis   2/32 (6.25%)  2 0/32 (0.00%)  0 3/29 (10.34%)  3 0/30 (0.00%)  0
impetigo   0/32 (0.00%)  0 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0
upper track respiratory infection   0/32 (0.00%)  0 0/32 (0.00%)  0 1/29 (3.45%)  1 1/30 (3.33%)  1
herpes simplex   0/32 (0.00%)  0 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0
tooth abscess   1/32 (3.13%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0
pharyngitis   0/32 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1
Injury, poisoning and procedural complications         
mouth injury   1/32 (3.13%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0
arthropod bite   0/32 (0.00%)  0 2/32 (6.25%)  2 0/29 (0.00%)  0 0/30 (0.00%)  0
epicondylitis   1/32 (3.13%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders         
headache   2/32 (6.25%)  2 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
pharyngolaryngeal pain   0/32 (0.00%)  0 2/32 (6.25%)  2 0/29 (0.00%)  0 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders         
erythema   1/32 (3.13%)  1 1/32 (3.13%)  1 0/29 (0.00%)  0 1/30 (3.33%)  1
sunburn   1/32 (3.13%)  1 0/32 (0.00%)  0 1/29 (3.45%)  1 1/30 (3.33%)  1
dermatitis contact   0/32 (0.00%)  0 1/32 (3.13%)  1 0/29 (0.00%)  0 2/30 (6.67%)  2
skin burning sensation   0/32 (0.00%)  0 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0
skin oedema   1/32 (3.13%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0
skin irritation   0/32 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Jean-Charles Dhuin
Organization: Galderma
Phone: +33492952921
Responsible Party: Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier: NCT00883233     History of Changes
Other Study ID Numbers: RD.03.SPR.29085
First Submitted: April 16, 2009
First Posted: April 17, 2009
Results First Submitted: October 11, 2010
Results First Posted: December 8, 2010
Last Update Posted: December 8, 2010