To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

  • End date
    Dec 29, 2022
  • participants needed
  • sponsor
    Cutia Therapeutics (Shanghai) Co., Ltd
Updated on 29 December 2021


This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.


Qualified subjects will be randomized to receive 1 of the following 2 treatments:

  • FMX101 4% minocycline foam
  • Vehicle foam

Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.

Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.

Condition Acne Vulgaris
Treatment FMX101
Clinical Study IdentifierNCT04960930
SponsorCutia Therapeutics (Shanghai) Co., Ltd
Last Modified on29 December 2021


Yes No Not Sure

Inclusion Criteria

Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF
Has facial acne vulgaris with
to 50 inflammatory lesions (papules, pustules, and nodules)
to 100 non-inflammatory lesions (open and closed comedones)
No more than 2 nodules on the face
IGA score of moderate (3) to severe (4)
Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
Cleanser) and to refrain from use of any other acne medication, medicated
cleanser, excessive sun exposure, and tanning booths for the duration of the

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
Sunburn on the face
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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