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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Adapalene/Benzoyl Peroxide

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97210
      • Phoebe Rich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapalene/Benzoyl Peroxide; 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; Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Local Tolerability Assessment For Erythema	Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe.	Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Scaling	Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production).	Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Dryness	Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness).	Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12
Number of Participants With Local Tolerability Assessment For Stinging/Burning	Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort).	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)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline up to Month 14
Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.	Baseline up to Month 14

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Michael Graeber, MD, Galderma R&D

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2004
• Primary Completion (Actual): May 23, 2005
• Study Completion (Actual): May 23, 2005

Study Registration Dates

• First Submitted: March 8, 2007
• First Submitted That Met QC Criteria: March 8, 2007
• First Posted (Estimated): March 12, 2007

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acne Vulgaris; Adapalene; Benzoyl Peroxide
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: RD.06.SPR.18089