A Safety and Efficacy Study to Evaluate Rosacea

AiViva BioPharma

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Papulopustular Rosacea

Treatments: Drug: AIV001; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03883945

AIV001-R01

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 8 patient groups, including a placebo group

Cohort 1 - vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Cohort 1 - 0.033%

Active Comparator group

Description:

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

Treatment:

Drug: AIV001

Cohort 2 - vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Cohort 2 - 0.1%

Active Comparator group

Description:

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

Treatment:

Drug: AIV001

Cohort 3 - vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Cohort 3 - 0.3%

Active Comparator group

Description:

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

Treatment:

Drug: AIV001

Cohort 4 - vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Cohort 4 - 1%

Active Comparator group

Description:

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

Treatment:

Drug: AIV001