Back to resultsA Safety and Efficacy Study to Evaluate Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIV001
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea focused on measuring rosacea
Eligibility Criteria
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
Sites / Locations
- Cosmetic Laser Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Cohort 1 - vehicle
Cohort 1 - 0.033%
Cohort 2 - vehicle
Cohort 2 - 0.1%
Cohort 3 - vehicle
Cohort 3 - 0.3%
Cohort 4 - vehicle
Cohort 4 - 1%
Arm Description
Subjects randomized to vehicle will receive vehicle administration to the target area.
Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.
Subjects randomized to vehicle will receive vehicle administration to the target area.
Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.
Subjects randomized to vehicle will receive vehicle administration to the target area.
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Subjects randomized to vehicle will receive vehicle administration to the target area.
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Outcomes
Primary Outcome Measures
Rate of Adverse Events
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
Secondary Outcome Measures
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
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.
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
Evaluation of Erythema and Topography using Standardized Photography
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03883945
Brief Title
A Safety and Efficacy Study to Evaluate Rosacea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor deprioritization
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AiViva BioPharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Study medication will be administered by the Treating Investigator. Safety and efficacy measures will be evaluated by the masked Evaluating Investigator.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to vehicle will receive vehicle administration to the target area.
Arm Title
Cohort 1 - 0.033%
Arm Type
Active Comparator
Arm Description
Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.
Arm Title
Cohort 2 - vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to vehicle will receive vehicle administration to the target area.
Arm Title
Cohort 2 - 0.1%
Arm Type
Active Comparator
Arm Description
Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.
Arm Title
Cohort 3 - vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to vehicle will receive vehicle administration to the target area.
Arm Title
Cohort 3 - 0.3%
Arm Type
Active Comparator
Arm Description
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Arm Title
Cohort 4 - vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to vehicle will receive vehicle administration to the target area.
Arm Title
Cohort 4 - 1%
Arm Type
Active Comparator
Arm Description
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Intervention Type
Drug
Intervention Name(s)
AIV001
Intervention Description
intradermal injection
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
intradermal injection
Primary Outcome Measure Information:
Title
Rate of Adverse Events
Description
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
Time Frame
Day 1 through Day 84
Secondary Outcome Measure Information:
Title
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Description
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.
Time Frame
Day 1 through Day 84
Title
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
Description
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
Time Frame
Day 1 through 84
Title
Evaluation of Erythema and Topography using Standardized Photography
Description
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.
Time Frame
Day 1 through 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Goldman, MD
Organizational Affiliation
West Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cosmetic Laser Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Safety and Efficacy Study to Evaluate Rosacea
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