A Safety and Efficacy Study to Evaluate Rosacea
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Cohort 1 - vehicle Subjects randomized to vehicle will receive vehicle administration to the target area. |
Drug: Vehicle
intradermal injection
|
| Active Comparator: Cohort 1 - 0.033% Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area. |
Drug: AIV001
intradermal injection
|
| Placebo Comparator: Cohort 2 - vehicle Subjects randomized to vehicle will receive vehicle administration to the target area. |
Drug: Vehicle
intradermal injection
|
| Active Comparator: Cohort 2 - 0.1% Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area. |
Drug: AIV001
intradermal injection
|
| Placebo Comparator: Cohort 3 - vehicle Subjects randomized to vehicle will receive vehicle administration to the target area. |
Drug: Vehicle
intradermal injection
|
| Active Comparator: Cohort 3 - 0.3% Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. |
Drug: AIV001
intradermal injection
|
| Placebo Comparator: Cohort 4 - vehicle Subjects randomized to vehicle will receive vehicle administration to the target area. |
Drug: Vehicle
intradermal injection
|
| Active Comparator: Cohort 4 - 1% Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. |
Drug: AIV001
intradermal injection
|
Outcome Measures
Primary Outcome Measures
- Rate of Adverse Events [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.
Secondary Outcome Measures
- Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale [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.
- Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts [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.
- Evaluation of Erythema and Topography using Standardized Photography [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cosmetic Laser Dermatology | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- AiViva BioPharma, Inc.
Investigators
- Principal Investigator: Mitchell Goldman, MD, West Dermatology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AIV001-R01