Status:

COMPLETED

Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects

Lead Sponsor:

Galderma R&D

Conditions:

Acne Vulgaris

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and...

Eligibility Criteria

Inclusion

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 Inflammatory lesions.
  • A minimum of 30 but not more than 100 Noninflammatory lesions.

Exclusion

  • Subjects with presence of nodules or cysts.
  • Acne conglobate, acne fulminans, secondary acne, or severe acne.
  • Underlying diseases that required the use of interfering topical or systemic therapy.
  • Use of prohibited medications prior to the study unless appropriate washout period was documented.

Key Trial Info

Start Date :

February 17 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 23 2005

Estimated Enrollment :

452 Patients enrolled

Trial Details

Trial ID

NCT00446043

Start Date

February 17 2004

End Date

May 23 2005

Last Update

July 11 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Phoebe Rich, MD

Portland, Oregon, United States, 97210