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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR ACZONE

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Clinical Trials for Aczone

Trial ID Title Status Sponsor Phase Summary
NCT00243542 Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency Completed Allergan Phase 4 The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders. ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne. The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone. G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency. Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
NCT00249782 A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea. Completed Allergan Phase 2 The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA. Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.
NCT00343187 A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash Terminated Allergan Phase 2 The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face
NCT01115244 Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis Unknown status Vanderbilt University N/A The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Success for lesion reduction will be defined as statistically greater mean percent reductions at week six in the dapsone gel-treated extremity compared with the control extremity of each patient.
NCT01231334 A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne Completed Allergan Phase 4 A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).
NCT01313728 A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products Completed Valeant Pharmaceuticals International, Inc. Phase 4 This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.
NCT01425320 Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne Withdrawn Allergan Phase 1 This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aczone

Condition Name

Condition Name for Aczone
Intervention Trials
Acne Vulgaris 9
Rosacea 1
Rash 1
Non-small-Cell Lung Cancer 1
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Condition MeSH

Condition MeSH for Aczone
Intervention Trials
Acne Vulgaris 10
Dermatitis 1
Lung Neoplasms 1
Carcinoma, Non-Small-Cell Lung 1
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Clinical Trial Locations for Aczone

Trials by Country

Trials by Country for Aczone
Location Trials
United States 73
Belize 1
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Trials by US State

Trials by US State for Aczone
Location Trials
Pennsylvania 6
Florida 5
California 5
New York 5
Texas 4
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Clinical Trial Progress for Aczone

Clinical Trial Phase

Clinical Trial Phase for Aczone
Clinical Trial Phase Trials
Phase 4 6
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Aczone
Clinical Trial Phase Trials
Completed 8
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Aczone

Sponsor Name

Sponsor Name for Aczone
Sponsor Trials
Allergan 6
Derm Research, PLLC 2
Taro Pharmaceuticals USA 2
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Sponsor Type

Sponsor Type for Aczone
Sponsor Trials
Industry 10
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
McKinsey
Queensland Health
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US Department of Justice
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Deloitte
Julphar
Moodys

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