A Safety and Efficacy Study to Evaluate Rosacea

NCT03883945 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: AIV001-R01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Papulopustular Rosacea

Keywords

rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale

  Day 1 through Day 84

• Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts

  Day 1 through 84

• Evaluation of Erythema and Topography using Standardized Photography

  Day 1 through 84

Study Arms (8)

Cohort 1 - vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Cohort 1 - 0.033%

ACTIVE COMPARATOR

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

Drug: AIV001

Cohort 2 - vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Cohort 2 - 0.1%

ACTIVE COMPARATOR

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

Drug: AIV001

Cohort 3 - vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Cohort 3 - 0.3%

ACTIVE COMPARATOR

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

Drug: AIV001

Cohort 4 - vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Cohort 4 - 1%

ACTIVE COMPARATOR

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

Drug: AIV001

Interventions

AIV001 DRUG

intradermal injection

Cohort 1 - 0.033%; Cohort 2 - 0.1%; Cohort 3 - 0.3%; Cohort 4 - 1%

Vehicle DRUG

intradermal injection

Cohort 1 - vehicle; Cohort 2 - vehicle; Cohort 3 - vehicle; Cohort 4 - vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mitchell Goldman, MD

  West Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study medication will be administered by the Treating Investigator. Safety and efficacy measures will be evaluated by the masked Evaluating Investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)