Overview

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

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Derm Research, PLLC
Collaborator:
Bayer
Treatments:
Azelaic acid
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