About this trial
This proof-of-concept trial evaluates the efficacy, safety, and patient satisfaction of topical minocycline foam (AMZEEQ®) in patients aged 9 and older with confluent and reticulated papillomatosis (CARP). Participants will apply AMZEEQ® to one side of the body and a topical emollient to the other for 5 weeks, followed by an optional extension period. The study aims to assess whether topical minocycline is a well-tolerated and effective alternative to oral antibiotics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 9 years
Clinical diagnosis of CARP
Disqualifiers
Current or recent (within 6 months) use of oral minocycline
Pregnancy or breastfeeding
History of intracranial hypertension, autoimmune disorder, liver/kidney disease
Immunocompromised status
Trial design
Crossover
Treatments tested in this trial
Topical Minocycline Foam FXFM244
DrugTopical minocycline foam that will be applied to half of the subject's body that will be chosen by the subject.
Control
Other interventionControl topical emollient that will be applied to the contralateral half of the body.
Treatment groups
Trial outcomes
Primary outcomes
Change in analog score based on blinded reviewer analysis of individuals treated with both daily topical AMZEEQ® (minocycline) compared to topical emollient
Comparison between the efficacy of topical minocycline foam and the control emollient. This will be completed by a dermatologist or dermatology resident that will be blinded to which side was treated with which intervention. Assessment will be completed through a visual analog used by the assessor where REDCap will assign a numeric value based on the position of the marking. The blinded photo reviewer will be informed whether the photo is a baseline or follow-up photo, but will be blinded to which side of the body was treatment or control. The photos will be marked to indicate the side of the body, and the photo reviewer will be asked to compare the left baseline side to the left follow-up side, and similarly the right baseline to the right follow-up, using a visual sliding analogue scale, where REDCap will assign a numeric value based on the position of the marking indicator. Average response to treatment among all patients will be determined.
Secondary outcomes
Assess possible adverse effects secondary to topical minocycline (AMZEEQ) use
Prior to beginning treatment, subjects will fill out a survey including the following conditions: headache, erythema, dry skin, hyperpigmentation, skin peeling, itching, GI upset, bone or muscle pain, photosensitivity, serious skin hypersensitivity reactions, delayed wound healing, nail changes, or infection. After completing the course of topical minocycline foam, patients will complete a follow up form again through REDCap which will be compared to the form completed at baseline.
Discern patient satisfaction with daily topical minocycline (AMZEEQ) use compared to daily topical emollient
To determine patient satisfaction, the Children's Dermatology Life Quality Index (CDLQI) survey for ages 4-16 or Dermatology Life Quality Index (DLQI) survey for ages 16+ will be administered at baseline before receiving the study drug and at each 6-week ± 5 day follow-up visit via REDCap. The CDLQI and DLQI surveys are the most frequently used validated, patient-reported outcome measure in dermatology trials. The DLQI is a 10-question, self-administered survey for patients over 16, designed to measure how skin conditions impact daily life over the past week. It covers symptoms, daily activities, leisure, work/school, personal relationships, and treatment, with a total score of 0-30 where higher scores indicate greater impairment. The CDLQI contains many of the same questions as the DLQI, but is administered to patients from the ages of 4 to 16.
Locations
Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
Journey Medical Corporation
Collaborator
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