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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02959970
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : December 3, 2018
Information provided by (Responsible Party):
Almirall, S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: dapsone gel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: ACZONE 7.5%
ACZONE (dapsone) gel 7.5% topically once daily for 12 weeks.
Drug: dapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.
Other Name: ACZONE

Primary Outcome Measures :
  1. Number of Participants with Treatment-Emergent Adverse Events [ Time Frame: 12 Weeks ]
  2. Trough Plasma Concentration of Dapsone [ Time Frame: Day 8, Pre-Dose ]
  3. Peak Plasma Concentration of Dapsone [ Time Frame: Day 8, 10 hours Post-Dose ]
  4. Patient-Rated Assessment of Stinging/Burning using a 4-Point Scale [ Time Frame: Week 12 ]
  5. Investigator-Rated Assessment of Dryness using a 4-Point Scale [ Time Frame: Week 12 ]
  6. Investigator-Rated Assessment of Scaling using a 4-Point Scale [ Time Frame: Week 12 ]
  7. Investigator-Rated Assessment of Erythema using a 4-Point Scale [ Time Frame: Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02959970

United States, Alabama
Kirklin Clinic
Birmingham, Alabama, United States, 35233
United States, California
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
Quest Dermatology Research
Northridge, California, United States, 91324
Southern California Dermatology
Santa Ana, California, United States, 92701
Redwood Family Dermatology
Santa Rosa, California, United States, 95401
United States, Florida
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Baumann Cosmetic and Research Institute
Miami Beach, Florida, United States, 33137
United States, Kentucky
Dermresearch, PLLC
Louisville, Kentucky, United States, 40217
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63104
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New York
Skin Specialty Dermatology
New York, New York, United States, 10155
United States, North Carolina
Health Sciences/Department of Dermatology
Winston-Salem, North Carolina, United States, 27106
United States, Pennsylvania
KGL Skin Study Center
Broomall, Pennsylvania, United States, 19008
Department of Dermatology, UPCII
Hershey, Pennsylvania, United States, 17033
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
DermResearch, LLC
Austin, Texas, United States, 78759
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78660
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Almirall, S.A.
Study Director: Cathy Truong Allergan

Additional Information:
Responsible Party: Almirall, S.A. Identifier: NCT02959970     History of Changes
Other Study ID Numbers: 1679-401-006
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents