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

NCT ID: NCT00883233

Last Updated: 2021-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

Adapalene-BPO 3-hour daily application before bedtime

Intervention Type DRUG

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

2

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

Group Type EXPERIMENTAL

Adapalene-BPO Gel every other day application

Intervention Type DRUG

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

3

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

Group Type EXPERIMENTAL

Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion

Intervention Type DRUG

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

4

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Group Type ACTIVE_COMPARATOR

Adapalene BPO Gel standard daily overnight application

Intervention Type DRUG

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Interventions

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Adapalene BPO Gel standard daily overnight application

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Intervention Type DRUG

Adapalene-BPO 3-hour daily application before bedtime

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

Intervention Type DRUG

Adapalene-BPO Gel every other day application

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

Intervention Type DRUG

Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion

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

Intervention Type DRUG

Other Intervention Names

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Standard 3-hour before bedtime every other day Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion

Eligibility Criteria

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Inclusion Criteria

* Male or female Subjects of any race, aged 12 to 35 years inclusive
* Subjects with mild or moderate facial acne vulgaris
* Subjects with skin phototype I to IV

Exclusion Criteria

* Subjects with more than 1 nodules or cysts on the face,
* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Galderma

Principal Investigators

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Jerry Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Windsor, ON, Canada

Locations

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Galderma Investigational Site

Windsor, Ontario, Canada

Site Status

Galderma Investigational Site

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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RD.03.SPR.29085

Identifier Type: -

Identifier Source: org_study_id

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