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Epiduo Pediatric Acne Study

2014-08-27 03:13:08 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Acne

Intervention

adapalene and benzoyl peroxide, Topical Gel Vehicle

Location

UAB Dermatology Clinical Research
Birmingham
Alabama
United States
35233

Status

Recruiting

Source

Galderma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:08-0400

Clinical Trials [984 Associated Clinical Trials listed on BioPortfolio]

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

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety ...

Adapalene-BPO Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously t...

A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%

The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl p...

A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and be...

Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, an...

PubMed Articles [2005 Associated PubMed Articles listed on BioPortfolio]

Management of Severe Acne Vulgaris With Topical Therapy.

Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Although rare in childhood, severe acne can affect up to 12% of the adolescent population. A chronic disease, it re...

Delivery of adapalene using a novel topical gel based on tea tree oil nano-emulsion: Permeation, antibacterial and safety assessments.

The aim of present study was to design and optimize 0.1% adapalene loaded nano-emulsion to improve the efficacy of the drug efficacy and increase its user compliance. Effect of type and concentration ...

Management of comedonal acne vulgaris with fixed-combination topical therapy.

Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Clinically, it is characterized by a combination of open and closed comedones (formally referred to as noninflammat...

A Qualitative Investigation of the Impact of Acne on Health-Related Quality of Life (HRQL): Development of a Conceptual Model.

The negative impact of acne on aspects of health-related quality of life (HRQL) has been demonstrated in many quantitative studies; however, there has been relatively little qualitative research explo...

Efficacy, Safety, and Tolerability of Topical Dapsone Gel, 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Phototype.

Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differen...

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 progesterone that has been used in ESTRUS SYNCHRONIZATION and has been evaluated as an injectable contraceptive in combination with estradiol enanthate. It is also used therapeutically as a topical anti-inflammatory and is applied topically in the treatment of ACNE.

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