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Completed

NCT Number: NCT01106807

Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Pharmaceuticals, Hot Springs, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subject has a clinical diagnosis of acne vulgaris with facial involvement
  • the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion criteria

  • subject has a severe acne form or secondary acne form
  • the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
  • the subject has a known allergy or sensitivity to any of the components of the study products
  • subject is not willing to respect wash-out periods for topical and/or systemic treatments

Treatment and study plan

Epiduo vehicle gel

Drug

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

CD07223

Drug

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

Drug

500 microliters Epiduo Gel on one of the half-face for the morning dose

Primary outcomes

  1. Total acne lesion count

    Time frame: 6 weeks

    change in total number of acne lesion count from baseline to end of treatment

  2. Percent change of acne lesion count

    Time frame: 6 weeks

    Percent change of acne lesion count from baseline to end of treatment

Secondary outcomes

  1. Lesion counts- Inflammatory

    Time frame: 6 weeks

    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  2. Lesion count- non-inflammatory

    Time frame: 6 weeks

    change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

  3. Lesion counts- Inflammatory

    Time frame: 6 weeks

    Percent change of acne lesion count from baseline at each evaluation visit

  4. Lesion count- non-inflammatory

    Time frame: 6 weeks

    Percent change of acne lesion count from baseline at each evaluation visit

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2010
Registry last updated
Feb 18, 2021

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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