Clinical trial NCT01038869: Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)
Official title: Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Post Inflammatory Hyperpigmentation
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2009-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)
timeFrame: Baseline to16 weeks
measure: Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution
timeFrame: Baseline to 16 weeks
measure: Percentage Change in Total Lesion Counts
timeFrame: Baseline to 16 weeks
measure: Tolerability Assessments as Measured by the Number of Participants With Side Effects
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: