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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Summary

The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12

Secondary outcome:

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.

Number of Participants With Tolerability Assessments Resulting in an Adverse Event

Eligibility

Minimum age: 16 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects, aged 16 to 25 years inclusive;

- Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) =

2 or 3;

- A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding

the nose);

- Subjects who agree to be photographed at each visit;

- Subjects who agree to be video recorded by study designated staff members. They

should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study Exclusion Criteria:

- Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne

(chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;

- Subjects with a wash-out period for topical acne treatment on the face less than 30

days

- Subjects with a wash-out period for systemic acne treatment less than 30 days with

the exception of isotretinoin which requires a washout of 4 months;

- Subjects who are currently being treated with antibiotics;

- Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain

sports, UV radiation, sunbathing, tanning beds, etc.);

- Subjects who refuse photographic and videography procedures and/or refuse to sign a

full release for their use in promotional materials

Locations and Contacts

Thomas J. Stephens and Associates, Carrollton, Texas 75006, United States
Additional Information

Starting date: October 2010
Last updated: January 18, 2012

Page last updated: August 23, 2015

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