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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02800148
• Collaborator: DPT Laboratories, Ltd. (Industry)
• Enrollment: 667
• Location: 1
• Arms: 3
• Actual Duration (Months): 11
• Patients Per Site Per Month: 60.8

Study Details

Study Description

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; Drug: Azelaic acid foam - Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 667 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azelaic acid foam	Drug: Azelaic acid foam
Active Comparator: Finacea Foam	Drug: Azelaic acid foam; Other Names: Finacea Foam
Placebo Comparator: Placebo Foam	Drug: Azelaic acid foam - Placebo

Outcome Measures

Primary Outcome Measures

1. Percent Change (Reduction) of Lesion Count From Day 1 [Day 84]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Consultants	High Point	North Carolina	United States	27262

Sponsors and Collaborators

• Padagis LLC
• DPT Laboratories, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 4, 2016
• Statistical Analysis Plan - Oct 4, 2016

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT02800148
• Other Study ID Numbers: PRG-NY-16-009
• First Posted: Jun 15, 2016
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rosacea; Azelaic acid

Study Results

Participant Flow

Arm/Group Title	Azelaic Acid Foam	Finacea Foam	Placebo Foam
Arm/Group Description	Azelaic acid foam	Azelaic acid foam	Azelaic acid foam - Placebo
Period Title: Overall Study
STARTED	224	224	219
COMPLETED	199	204	194
NOT COMPLETED	25	20	25

Baseline Characteristics

Arm/Group Title	Azelaic Acid Foam	Finacea Foam	Placebo Foam	Total
Arm/Group Description	Azelaic acid foam	Azelaic acid foam	Azelaic acid foam - Placebo	Total of all reporting groups
Overall Participants	224	224	219	667
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.6 (13.85)	51.5 (13.67)	49.0 (12.42)	50.7 (13.37)
Sex: Female, Male (Count of Participants)
Female	164 73.2%	167 74.6%	166 75.8%	497 74.5%
Male	60 26.8%	57 25.4%	53 24.2%	170 25.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	60 26.8%	55 24.6%	68 31.1%	183 27.4%
Not Hispanic or Latino	164 73.2%	169 75.4%	151 68.9%	484 72.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.4%	3 1.4%	4 0.6%
Asian	1 0.4%	5 2.2%	3 1.4%	9 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	2 0.9%	1 0.5%	3 0.4%
White	221 98.7%	215 96%	211 96.3%	647 97%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 0.9%	1 0.4%	1 0.5%	4 0.6%

Outcome Measures

1. Primary Outcome

Title	Percent Change (Reduction) of Lesion Count From Day 1
Time Frame	Day 84

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Azelaic Acid Foam	Finacea Foam	Placebo Foam
Arm/Group Description	Azelaic acid foam	Azelaic acid foam	Azelaic acid foam - Placebo
Measure Participants	178	181	178
Mean (Standard Deviation) [percentage of lesion reduction]	61.14 (33.623)	57.27 (34.513)	49.43 (44.437)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Azelaic Acid Foam, Finacea Foam
	Comments
	Type of Statistical Test	Equivalence
	Comments	provides 85% power of success
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	equivalence ratio
	Estimated Value	107
	Confidence Interval	(2-Sided) 90%; 96.1 to 115.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	84 days
Arm/Group Title	Azelaic Acid Foam		Finacea Foam		Placebo Foam
Arm/Group Description	Azelaic acid foam		Azelaic acid foam		Azelaic acid foam - Placebo
All Cause Mortality
	Azelaic Acid Foam		Finacea Foam		Placebo Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/224 (0%)		0/224 (0%)		0/219 (0%)
Serious Adverse Events
	Azelaic Acid Foam		Finacea Foam		Placebo Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/224 (0.4%)		0/224 (0%)		2/219 (0.9%)
Infections and infestations
Aseptic Meningitis	0/224 (0%)		0/224 (0%)		1/219 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal Cancer	1/224 (0.4%)		0/224 (0%)		0/219 (0%)
Psychiatric disorders
Major Depression	0/224 (0%)		0/224 (0%)		1/219 (0.5%)
Suicidal ideation	0/224 (0%)		0/224 (0%)		1/219 (0.5%)
Other (Not Including Serious) Adverse Events
	Azelaic Acid Foam		Finacea Foam		Placebo Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/224 (0%)		0/224 (0%)		0/219 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI's cannot disclose trial results under any circumstances.