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Completed

NCT Number: NCT01038869

Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Hyperpigmentation Pigmentation Disorders Post Inflammatory Hyperpigmentation 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

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, at least 12 years of age
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
  • Fitzpatrick skin type IV to VI
  • Acne IGA (Investigator Global Assessment) score of 2 or 3
  • Inflammatory lesions of 15-60 (with no more than 2 nodules)
  • Non-inflammatory lesions of 20-100
  • Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5
  • Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian

Exclusion criteria

  • Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control
  • Allergy or sensitivity to any component of the test medication
  • Subjects who have not complied with the wash out periods for prohibited medications
  • Medical condition that contraindicates participation
  • Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH
  • Evidence of recent alcohol or drug abuse
  • History of poor cooperation, non-compliance or unreliability
  • Exposure to an investigational drug study within 30 day of Baseline visit

Treatment and study plan

Azelaic acid

Drug

Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.

Other names: Finacea

Primary outcomes

  1. Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)

    Time frame: Baseline to 16 weeks

    IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.

Secondary outcomes

  1. Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)

    Time frame: Baseline to16 weeks

    IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement

  2. Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution

    Time frame: Baseline to 16 weeks

    The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%

  3. Percentage Change in Total Lesion Counts

    Time frame: Baseline to 16 weeks

    Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).

  4. Tolerability Assessments as Measured by the Number of Participants With Side Effects

    Time frame: 16 weeks

    Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus

Sponsors and collaborators

Lead sponsor

Derm Research, PLLC

Other

Collaborators

  • Bayer

Registry information

Official study title

Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 24, 2009
Registry last updated
Sep 25, 2012

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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