Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

Galderma R&D459 enrolled

Overview

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

459

Conditions

Severe Acne Vulgaris

Interventions

Adapalene BPO Gel associated with Doxycyline HyclateDRUG

Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

Vehicle Gel associated with Doxycycline HyclateDRUG

Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female Subjects of any race, aged 12 to 35 years inclusive * Subjects with severe facial acne (global severity score of 4) * Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose * Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: * Subjects with more than 3 nodules or cysts on the face, * Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Locations (34)

Outcomes

Primary Outcomes

Percent Change From Baseline in Total Lesion Counts at Week 12.

Time frame: Week 12

Secondary Outcomes

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.

Time frame: Week 12

Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12

Time frame: Week 12

Success Rate on the Investigator's Global Assessment

Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12

Time frame: Week 12

Percent of Subjects With Adverse Events

Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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Galderma Investigational Site

Oceanside, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Miami, Florida, United States

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Snellville, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

...and 24 more locations