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A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

2014-08-27 03:39:43 | BioPortfolio

Summary

This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

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

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acne Vulgaris

Intervention

Adapalene/Benzoyl Peroxide

Location

Phoebe Rich, MD
Portland
Oregon
United States
97210

Status

Completed

Source

Galderma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:43-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of adapalene and benzoyl peroxide that is used as a DERMATOLOGIC AGENT for the topical treatment of ACNE.

A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.

A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

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