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

This study has been completed.
Sponsor:
Collaborator:
Intendis, Inc.
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT01038869
First received: December 23, 2009
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  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
U.S. FDA Resources

Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) [ Time Frame: Baseline to16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus


Enrollment: 20
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: 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

  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 (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
  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., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01038869     History of Changes
Other Study ID Numbers: FIN0901
Study First Received: December 23, 2009
Results First Received: March 26, 2012
Last Updated: August 24, 2012
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 21, 2013