Phase 4 N=20 Treatment

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

Acne Vulgaris · Post Inflammatory Hyperpigmentation

Bottom Line

View on ClinicalTrials.gov: NCT01038869 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) — 92 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Azelaic acid (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Derm Research, PLLC
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)	92	—
SECONDARY Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)	100	—
SECONDARY Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution	92; 100	—
SECONDARY Percentage Change in Total Lesion Counts	-92.4	—
SECONDARY Tolerability Assessments as Measured by the Number of Participants With Side Effects	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01038869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.