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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446043
• Other study ID #: RD.06.SPR.18089
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2004
• Est. completion date: May 23, 2005

Study information

• Verified date: August 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: May 23, 2005
• Est. primary completion date: May 23, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	Phoebe Rich, MD	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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