Topical Minocycline for CARP

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age9+
SponsorMedical University of South Carolina

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Topical Minocycline Foam FXFM244

    Drug

    Topical minocycline foam that will be applied to half of the subject's body that will be chosen by the subject.

  • Control

    Other intervention

    Control topical emollient that will be applied to the contralateral half of the body.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Experimental Half of the BodyExperimental treatment 1 intervention
Group B: Control Half of the BodyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 +/- 1 weeks

Secondary outcomes

1

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.

Time frame
6 +/- 1 weeks
2

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.

Time frame
6 +/- 1 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Journey Medical Corporation

Collaborator

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