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OpenTrials
Completed

NCT Number: NCT02944461

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

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

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatology and Laser Surgery, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dapsone 7.5 % gel

Drug

Dapsone gel 7.5% applied once daily to truncal acne

Other names: Aczone

Primary outcomes

  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 outcomes

  1. The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline

    Time frame: 16 Weeks

  2. The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline

    Time frame: 16 Weeks

  3. The Percent Change in Total Lesion Count at Week 16 Compared to Baseline

    Time frame: 16 Weeks

Sponsors and collaborators

Lead sponsor

Derm Research, PLLC

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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