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.
Post Inflammatory Hyperpigmentation
Drug: Azelaic acid
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris|
- Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]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.
- Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) [ Time Frame: Baseline to16 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus
|Study Start Date:||December 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Azelaic acid 15% (Finacea)
Open label pilot study, Topical gel to be appiled twice daily for 16 weeks
Drug: Azelaic acid
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 Name: Finacea
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038869
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|
|Principal Investigator:||Leon H. Kircik, M.D.||DermResearch, PLLC|