- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883945
A Safety and Efficacy Study to Evaluate Rosacea
May 11, 2022 updated by: AiViva BioPharma, Inc.
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea.
Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Cosmetic Laser Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and < 2 nodules
- Presence of moderate to severe persistent erythema
- Total body weight >45 kg
Exclusion Criteria:
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
- Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
- Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
- Hypersensitivity or allergy to axitinib or any other component of the study treatment
- Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Use within 6 weeks prior to baseline and during the study of vasodilators or α-adrenergic receptor-blocking agents.
- Use within 1 month prior to baseline and during the study of 1) topical retinoids to the face, 2) systemic antibiotics know to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4) facial light-based therapies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Cohort 1 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
|
intradermal injection
|
Active Comparator: Cohort 1 - 0.033%
Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.
|
intradermal injection
|
Placebo Comparator: Cohort 2 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
|
intradermal injection
|
Active Comparator: Cohort 2 - 0.1%
Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.
|
intradermal injection
|
Placebo Comparator: Cohort 3 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
|
intradermal injection
|
Active Comparator: Cohort 3 - 0.3%
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
|
intradermal injection
|
Placebo Comparator: Cohort 4 - vehicle
Subjects randomized to vehicle will receive vehicle administration to the target area.
|
intradermal injection
|
Active Comparator: Cohort 4 - 1%
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
|
intradermal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Adverse Events
Time Frame: Day 1 through Day 84
|
The occurrence of adverse events will be collected and reported using MedDRA to code.
Description, start and end dates, and severity will be recorded.
|
Day 1 through Day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Time Frame: Day 1 through Day 84
|
Evaluation of rosacea within the treatment area.
0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia).
Scores of 0 or 1 are considered success.
|
Day 1 through Day 84
|
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
Time Frame: Day 1 through 84
|
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
|
Day 1 through 84
|
Evaluation of Erythema and Topography using Standardized Photography
Time Frame: Day 1 through 84
|
Photographs using standardized equipment will be taken and uploaded onto the vendor's server.
The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area.
|
Day 1 through 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mitchell Goldman, MD, West Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
March 16, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 21, 2019
Study Record Updates
Last Update Posted (Actual)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIV001-R01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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