Clinical TrialID 6916

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

NCT00883233

Acne

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Record Fields

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Clinical Trial Id
6916
Evidence Id
6916
Core Evidence Id
6916
Source Clinical Trial Id
6908
Herb2 Clinical Trial Id
HBCT006908
Nct Id
NCT00883233
Title
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Status
Completed
Phase
Phase 3
Study Result
Yes
Study Condition
Acne
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
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
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Single
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult
Enrollment
123
Outcome Measure
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline., 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., Week 4
Sponsor Collaborator
Galderma R&D
Funded By
INDUSTRY
Location
Galderma Investigational Site, Windsor, Ontario, Canada|Galderma Investigational Site, Montreal, Quebec, Canada
Other Id
RD.03.SPR.29085
Start Date
2009-04
Primary Completion Date
2009-09
Completion Date
2009-09
First Posted
2009-04-17
Results First Posted
2010-12-08
Last Update Posted
2021-02-18
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00883233
Title Cn
Title En
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Bilingual Status
semi_complete