Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)
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|ClinicalTrials.gov Identifier: NCT01038869|
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Post Inflammatory Hyperpigmentation||Drug: Azelaic acid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||May 2010|
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038869
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|
|Principal Investigator:||Leon H. Kircik, M.D.||DermResearch, PLLC|