Clinical trial NCT00446043: Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Official title: A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Adapalene
Benzoyl Peroxide
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-03-12
Enrollment: 452
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
timeFrame: Baseline, Month 12 LOCF
measure: Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
timeFrame: At Month 6
measure: Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
timeFrame: At Month 12
Secondary outcomes:
measure: Number of Participants With Local Tolerability Assessment For Erythema
timeFrame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
measure: Number of Participants With Local Tolerability Assessment For Scaling
timeFrame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
measure: Number of Participants With Local Tolerability Assessment For Dryness
timeFrame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
measure: Number of Participants With Local Tolerability Assessment For Stinging/Burning
timeFrame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
measure: Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: Baseline up to Month 14
measure: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Baseline up to Month 14
Other outcomes:
Locations:
city: Portland
country: United States
facility: Phoebe Rich, MD
state: Oregon
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References:
citation: Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.