Clinical trial NCT03883945: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Papulopustular Rosacea
Keywords: rosacea
Lead sponsor: AiViva BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Adverse Events
timeFrame: Day 1 through Day 84
Secondary outcomes:
measure: Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
timeFrame: Day 1 through Day 84
measure: Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
timeFrame: Day 1 through 84
measure: Evaluation of Erythema and Topography using Standardized Photography
timeFrame: Day 1 through 84
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
Study officials:
affiliation: West Dermatology
name: Mitchell Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: