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

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ClinicalTrials.gov Identifier: NCT01038869
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Post Inflammatory Hyperpigmentation Drug: Azelaic acid Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris
Study Start Date : December 2009
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) [ Time Frame: Baseline to 16 weeks ]
    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 :
  1. Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH) [ Time Frame: Baseline to16 weeks ]
    IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement

  2. Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution [ Time Frame: Baseline to 16 weeks ]
    The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%

  3. Percentage Change in Total Lesion Counts [ Time Frame: Baseline to 16 weeks ]
    Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).

  4. Tolerability Assessments as Measured by the Number of Participants With Side Effects [ Time Frame: 16 weeks ]
    Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus


Eligibility Criteria

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038869


Locations
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
Bayer
Investigators
Principal Investigator: Leon H. Kircik, M.D. DermResearch, PLLC
More Information

Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01038869     History of Changes
Other Study ID Numbers: FIN0901
First Posted: December 24, 2009    Key Record Dates
Results First Posted: September 25, 2012
Last Update Posted: September 25, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Acne Vulgaris
Hyperpigmentation
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pigmentation Disorders
Azelaic acid
Antineoplastic Agents
Dermatologic Agents