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Trial record 59 of 233 for:    acne AND Percent

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01209949
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Enrollment 30
Recruitment Details

Dates of recruitment period: First subject was enrolled on October 7, 2010 and the last subject was enrolled on October 12, 2010.

Types of location: Investigative site was located at a research center.

Pre-assignment Details Wash-out period up to baseline was 30 days for topical and systemic acne treatments with the exception of isotretinoin, which had a wash-out period of 4 months.
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
17.5  (1.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
1.Primary Outcome
Title Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
Hide Description Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (subjects with a baseline and week 12 visit)
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description:
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
18
2.Secondary Outcome
Title Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
Hide Description Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (subjects with a baseline and week 12 visit)
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description:
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
Inflammatory Lesions -44.1  (34.79)
Noninflammatory Lesions -57.1  (19.83)
Total Lesions -49.7  (24.06)
3.Secondary Outcome
Title Number of Participants With Tolerability Assessments Resulting in an Adverse Event
Hide Description Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description:
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
2
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Hide Arm/Group Description Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
All-Cause Mortality
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Affected / at Risk (%)
Total   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 5%
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel
Affected / at Risk (%)
Total   0/30 (0.00%) 
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.
The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
Results Point of Contact
Name/Title: Norman Preston
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5360
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01209949     History of Changes
Other Study ID Numbers: US10179
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: December 13, 2011
Results First Posted: January 19, 2012
Last Update Posted: January 19, 2012