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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. Identifier: NCT02800148
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
DPT Laboratories, Ltd.
Information provided by (Responsible Party):
Perrigo Company

Brief Summary:
To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Azelaic acid foam Drug: Azelaic acid foam - Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Azelaic acid foam Drug: Azelaic acid foam
Active Comparator: Finacea Foam Drug: Azelaic acid foam
Other Name: Finacea Foam

Placebo Comparator: Placebo Foam Drug: Azelaic acid foam - Placebo

Primary Outcome Measures :
  1. Percent Change (Reduction) of Lesion Count From Day 1 [ Time Frame: Day 84 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02800148

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United States, North Carolina
Dermatology Consultants
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Perrigo Company
DPT Laboratories, Ltd.
  Study Documents (Full-Text)

Documents provided by Perrigo Company:
Study Protocol  [PDF] October 4, 2016
Statistical Analysis Plan  [PDF] October 4, 2016

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Responsible Party: Perrigo Company Identifier: NCT02800148    
Other Study ID Numbers: PRG-NY-16-009
First Posted: June 15, 2016    Key Record Dates
Results First Posted: December 9, 2020
Last Update Posted: December 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents