A Safety and Efficacy Study to Evaluate Rosacea

Study Overview
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Brief Summary
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To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.

Detailed Description
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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.

Official Title
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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

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: AIV001
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1 - vehicle<br>Subjects randomized to vehicle will receive vehicle administration to the target area. | Drug: Vehicle<br>* intradermal injection<br>|
| Active Comparator: Cohort 1 - 0.033%<br>Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area. | Drug: AIV001<br>* intradermal injection<br>|
| Placebo Comparator: Cohort 2 - vehicle<br>Subjects randomized to vehicle will receive vehicle administration to the target area. | Drug: Vehicle<br>* intradermal injection<br>|
| Active Comparator: Cohort 2 - 0.1%<br>Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area. | Drug: AIV001<br>* intradermal injection<br>|
| Placebo Comparator: Cohort 3 - vehicle<br>Subjects randomized to vehicle will receive vehicle administration to the target area. | Drug: Vehicle<br>* intradermal injection<br>|
| Active Comparator: Cohort 3 - 0.3%<br>Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. | Drug: AIV001<br>* intradermal injection<br>|
| Placebo Comparator: Cohort 4 - vehicle<br>Subjects randomized to vehicle will receive vehicle administration to the target area. | Drug: Vehicle<br>* intradermal injection<br>|
| Active Comparator: Cohort 4 - 1%<br>Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. | Drug: AIV001<br>* intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosacea