Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 11
Updated:12/5/2018
Start Date:October 31, 2016
End Date:February 8, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of
ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with
acne vulgaris.


Inclusion Criteria:

-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions
(noninflammatory and/or inflammatory).

Exclusion Criteria:

- Has uncontrolled systemic disease(s)

- Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne,
drug-induced acne)

- Has used topical dapsone within 1 month prior to the screening

- Has used oral dapsone within 2 months prior to screening.
We found this trial at
20
sites
Quest Dermatology Research
18546 Roscoe Boulevard
Northridge, California 91324
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Northridge, CA
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Arlington Research Center
Arlington, Texas 76011
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mi
from
Arlington, TX
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DermResearch, Inc.
Austin, Texas 78759
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mi
from
Austin, TX
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The Center for Clinical and Cosmetic Research
Aventura, Florida 33180
?
mi
from
Aventura, FL
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Kirklin Clinic
Birmingham, Alabama 35233
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mi
from
Birmingham, AL
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KGL Skin Study Center
Broomall, Pennsylvania 19008
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mi
from
Broomall, PA
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Hamzavi Dermatology
Fort Gratiot, Michigan 48059
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mi
from
Fort Gratiot, MI
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Center for Dermatology Clinical Research
Fremont, California 94538
?
mi
from
Fremont, CA
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Department of Dermatology, UPCII
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
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University of Texas Medical School in Houston
Houston, Texas 77030
?
mi
from
Houston, TX
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DermResearch, PLLC
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
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Baumann Cosmetic and Research Institute
4500 Biscayne Boulevard
Miami Beach, Florida 33140
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mi
from
Miami Beach, FL
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Skin Specialty Dermatology
New York, New York 10155
?
mi
from
New York, NY
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Skin Specialists, PC
Omaha, Nebraska 68144
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mi
from
Omaha, NE
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Austin Institute for Clinical Research, Inc.
Pflugerville, Texas 78660
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mi
from
Pflugerville, TX
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Saint Louis University Dermatology
Saint Louis, Missouri 63104
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mi
from
Saint Louis, MO
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Southern California Dermatology, Inc.
Santa Ana, California 92701
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mi
from
Santa Ana, CA
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Redwood Family Dermatology
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
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Premier Clinical Research
Spokane, Washington 99204
?
mi
from
Spokane, WA
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Health Sciences/Department of Dermatology
Winston-Salem, North Carolina 27106
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mi
from
Winston-Salem, NC
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