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A Safety and Efficacy Study to Evaluate Rosacea

NCT ID: NCT03883945

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-08-31

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.

Conditions

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Papulopustular Rosacea

Keywords

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rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Study medication will be administered by the Treating Investigator. Safety and efficacy measures will be evaluated by the masked Evaluating Investigator.

Study Groups

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Cohort 1 - vehicle

Subjects randomized to vehicle will receive vehicle administration to the target area.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

intradermal injection

Cohort 1 - 0.033%

Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.

Group Type ACTIVE_COMPARATOR

AIV001

Intervention Type DRUG

intradermal injection

Cohort 2 - vehicle

Subjects randomized to vehicle will receive vehicle administration to the target area.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

intradermal injection

Cohort 2 - 0.1%

Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.

Group Type ACTIVE_COMPARATOR

AIV001

Intervention Type DRUG

intradermal injection

Cohort 3 - vehicle

Subjects randomized to vehicle will receive vehicle administration to the target area.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

intradermal injection

Cohort 3 - 0.3%

Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.

Group Type ACTIVE_COMPARATOR

AIV001

Intervention Type DRUG

intradermal injection

Cohort 4 - vehicle

Subjects randomized to vehicle will receive vehicle administration to the target area.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

intradermal injection

Cohort 4 - 1%

Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.

Group Type ACTIVE_COMPARATOR

AIV001

Intervention Type DRUG

intradermal injection

Interventions

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AIV001

intradermal injection

Intervention Type DRUG

Vehicle

intradermal injection

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AiViva BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

West Dermatology

Locations

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Cosmetic Laser Dermatology

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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AIV001-R01

Identifier Type: -

Identifier Source: org_study_id