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Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02944461
Recruitment Status : Unknown
Verified October 2016 by Derm Research, PLLC.
Recruitment status was:  Recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Derm Research, PLLC

Brief Summary:
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Condition or disease Intervention/treatment Phase
Acne Drug: Dapsone 7.5 % gel Phase 4

Detailed Description:
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Study Start Date : October 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: Dapsone gel 7.5%
Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
Drug: Dapsone 7.5 % gel
Dapsone gel 7.5% applied once daily to truncal acne
Other Name: Aczone




Primary Outcome Measures :
  1. Percent of subjects who achieve at least a two grade improvement and a rating of clear or almost clear on the Investigator Global Assessment (IGA) scale [ Time Frame: 16 weeks ]
    Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe


Secondary Outcome Measures :
  1. The percent reduction in Inflammatory lesion count at Week 16 compared to Baseline [ Time Frame: 16 Weeks ]
  2. The percent reduction in non-inflammatory lesion count at Week 16 compared to baseline [ Time Frame: 16 Weeks ]
  3. The percent reduction in total lesion count at Week 16 compared to Baseline [ Time Frame: 16 Weeks ]

Other Outcome Measures:
  1. Erythema [ Time Frame: 16 weeks ]
    The Investigator will grade the occurrence of erythema using a scale of : 0 = absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe

  2. Dryness [ Time Frame: 16 weeks ]
    The Investigator will grade the occurrence of dryness using a scale of : 0 = absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe

  3. Peeling [ Time Frame: 16 weeks ]
    The Investigator will grade the occurrence of peeling using a scale of : 0 = absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe

  4. Oiliness [ Time Frame: 16 weeks ]
    The Investigator will grade the occurrence of oiliness using a scale of : 0 = absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe

  5. Pruritus [ Time Frame: 16 Weeks ]
    The Investigator will interview the subject to determine the severity of pruritis as per the following: 0 = Absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 Marked, 5 = Severe

  6. Burning [ Time Frame: 16 Weeks ]
    The Investigator will interview the subject to determine the severity of burning as per the following: 0 = Absent, 1 = Trace, 2 = Mild, 3 = Moderate, 4 Marked, 5 = Severe

  7. Adverse Events [ Time Frame: 16 Weeks ]
    Subjects will be monitored for signs and symptoms of Adverse Events



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects of any race and at least 12 years of age.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
  • Truncal acne IGA score of 3.
  • Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

  • Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
  • Subjects who have an allergy or sensitivity to any component of the test medication.
  • Subjects who have not complied with the proper wash out periods for prohibited medications.
  • Evidence of recent drug or alcohol abuse.
  • Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
  • Exposure to an investigational drug within 30 days of the Baseline visit.
  • Medical condition that contraindicates the subject's participation in the study.
  • History of poor cooperation, non-compliance with medical treatment or unreliability.

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 ClinicalTrials.gov identifier (NCT number): NCT02944461


Contacts
Contact: Leon H. Kircik, M.D. 502-451-9000 wedoderm@yahoo.com
Contact: Deborah Zuidema, M.S.N. 502-456-4161 dbzuidema@aol.com

Locations
United States, California
Dermatology and Laser Surgery Recruiting
Sacramento, California, United States, 95819
Contact: Emil Tanghetti, M.D.         
United States, Kentucky
DermResearch, PLLC Recruiting
Louisville, Kentucky, United States, 40014
Contact: Deborah Zuidema, M.S.N.    502-456-4161    dbzuidema@aol.com   
Principal Investigator: Leon H. Kircik, M.D.         
United States, Nevada
James Q. DelRosso DO, LLC Recruiting
Las Vegas, Nevada, United States, 89117
Contact: James Q. DelRosso, D.O.         
Sponsors and Collaborators
Derm Research, PLLC
Investigators
Study Director: Leon H. Kircik, M.D. DermResearch PLLC

Responsible Party: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT02944461     History of Changes
Other Study ID Numbers: ACZ1601
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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