Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation - Full Text View

Sponsor:	Derm Research, PLLC
Collaborator:	Intendis, Inc.
Information provided by:	Derm Research, PLLC
ClinicalTrials.gov Identifier:	NCT01038869

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris Post Inflammatory Hyperpigmentation	Drug: Azelaic acid	Phase 4

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:

Acne IGA [ Time Frame: Baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PIH IGA [ Time Frame: Baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
PIH % Distribution [ Time Frame: Baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
Lesion Counts [ Time Frame: Baseline and every 4 weeks for 16 weeks ] [ Designated as safety issue: No ]
Tolerability Assessments [ Time Frame: Baseline andevery 4 weeks for 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	December 2009
Study Completion Date:	May 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Finacea Open label pilot study	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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 score of 2 or 3
Inflammatory lesions of 15-60 (with no more than 2 nodules)
Non-inflammatory lesions of 20-100
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038869

Locations

United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217

Sponsors and Collaborators

Derm Research, PLLC

Intendis, Inc.

Investigators

Principal Investigator:

Leon H. Kircik, M.D.

DermResearch, PLLC

More Information

No publications provided

Responsible Party:	Leon Kircik, M.D., DermResearch, PLLC
ClinicalTrials.gov Identifier:	NCT01038869 History of Changes
Other Study ID Numbers:	FIN0901
Study First Received:	December 23, 2009
Last Updated:	June 30, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Acne Vulgaris
Hyperpigmentation
Pigmentation Disorders
Acneiform Eruptions
Skin Diseases
Facial Dermatoses

Sebaceous Gland Diseases
Azelaic acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 24, 2012