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Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800148
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
DPT Laboratories, Ltd.
Information provided by (Responsible Party):
Perrigo Company

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
Percent reduction of lesion count from Day 1 [ Time Frame: Day 84 ]
Description
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Percent reduction of lesion count from Day 1 [ Time Frame: Day 84 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face
Official Title  ICMJE Not Provided
Brief Summary To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • Drug: Azelaic acid foam
  • Drug: Azelaic acid foam
    Other Name: Finacea Foam
  • Drug: Azelaic acid foam - Placebo
Study Arms  ICMJE
  • Experimental: Azelaic acid foam
    Intervention: Drug: Azelaic acid foam
  • Active Comparator: Finacea Foam
    Intervention: Drug: Azelaic acid foam
  • Placebo Comparator: Placebo Foam
    Intervention: Drug: Azelaic acid foam - Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2017)
665
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
600
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must sign an Institutional Review Board (IRB) approved written informed consent for this study.
  2. Subjects must be at least 18 years of age.
  3. Subjects must have a definite clinical diagnosis of moderate to facial papulopustular rosacea,
  4. Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other
  5. Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
  6. Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

  1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
  2. Current or past ocular rosacea
  3. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment
  4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in judgment of the Investigator, would put the subject at undue risk or might confound the study assessments
  5. Currently using any product containing Azelaic Acid/or belonging to the same family as Azelaic Acid foam, 15%.
  6. Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout the study.
  7. History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, and/or any ingredient in the study medication.
  8. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
  9. Current use of anticoagulation therapy and use throughout the study.
  10. Use of medicated make-up (including anti-aging make-up) throughout the study
  11. Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
  12. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
  13. Use of medicated cleansers on the face throughout the study.
  14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
  15. Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
  16. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
  17. Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
  18. Previous enrollment in this study or current enrollment in this study at another participating site.
  19. Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
  20. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800148
Other Study ID Numbers  ICMJE PRG-NY-16-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Perrigo Company
Study Sponsor  ICMJE Perrigo Company
Collaborators  ICMJE DPT Laboratories, Ltd.
Investigators  ICMJE Not Provided
PRS Account Perrigo Company
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP