A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2019-02-11

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FMX101 vehicle

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)

Group Type EXPERIMENTAL

FMX101 vehicle

Intervention Type DRUG

FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)

Hydro-alcohol solution base

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)

Group Type EXPERIMENTAL

Hydro-alcohol solution

Intervention Type OTHER

Hydro-alcohol solution based vehicle (Test Article B)

Interventions

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FMX101 vehicle

FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)

Intervention Type DRUG

Hydro-alcohol solution

Hydro-alcohol solution based vehicle (Test Article B)

Intervention Type OTHER

Other Intervention Names

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Test Article A Test Article B

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No