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

NCT00446043 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18089
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Adapalene; Benzoyl Peroxide

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF

  Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).

  Baseline, Month 12 LOCF

• Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6

  Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.

  At Month 6

• Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12

  Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.

  At Month 12

Secondary Outcomes (6)

• Number of Participants With Local Tolerability Assessment For Erythema

  Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

• Number of Participants With Local Tolerability Assessment For Scaling

  Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

• Number of Participants With Local Tolerability Assessment For Dryness

  Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

• Number of Participants With Local Tolerability Assessment For Stinging/Burning

  Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

• Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)

  Baseline up to Month 14

Study Arms (1)

Adapalene/Benzoyl Peroxide

EXPERIMENTAL

Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.

Drug: Adapalene/Benzoyl Peroxide

Interventions

Adapalene/Benzoyl Peroxide DRUG

Adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

Adapalene/Benzoyl Peroxide

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Phoebe Rich, MD

Portland, Oregon, 97210, United States

Location

Related Publications (1)

• 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.

  PMID: 12963896 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adapalene; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 12, 2007
• Study Start: February 17, 2004
• Primary Completion: May 23, 2005
• Study Completion: May 23, 2005
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2022-08

Locations

US (1)