A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Vyne Therapeutics

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Other: Hydro-alcohol solution; Drug: FMX101 vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03743038

FX2018-23

Details and patient eligibility

About

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).

Full description

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.

Enrollment: 12 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has facial acne vulgaris with:

  16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face

Exclusion criteria

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
• More than two facial nodules/cysts
• Sunburn on the face

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

FMX101 vehicle

Experimental group

Description:

FMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model)

Treatment:

Drug: FMX101 vehicle

Hydro-alcohol solution base

Experimental group

Description:

Hydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model)

Treatment:

Other: Hydro-alcohol solution