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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Derm Research, PLLC

Current Primary Outcome: 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.


Original Primary Outcome: Acne IGA [ Time Frame: Baseline and every 4 weeks for 16 weeks ]

Current Secondary Outcome:

  • 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
  • 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%
  • 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).
  • 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


Original Secondary Outcome:

  • PIH IGA [ Time Frame: Baseline and every 4 weeks for 16 weeks ]
  • PIH % Distribution [ Time Frame: Baseline and every 4 weeks for 16 weeks ]
  • Lesion Counts [ Time Frame: Baseline and every 4 weeks for 16 weeks ]
  • Tolerability Assessments [ Time Frame: Baseline andevery 4 weeks for 16 weeks ]


Information By: Derm Research, PLLC

Dates:
Date Received: December 23, 2009
Date Started: December 2009
Date Completion:
Last Updated: August 24, 2012
Last Verified: August 2012