Topical Minocycline for CARP

March 5, 2026 updated by: Lara Wine Lee, Medical University of South Carolina

Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Confluent and reticulated papillomatosis (CARP) is a dermatologic condition consisting of primarily truncal hyperpigmented and hyperkeratotic papules and macules in adolescents. The exact cause is unclear, though a gram-positive actinomycete, Dietzia papillomatosis, likely plays a role. Resolution of the rash could take a year or even years to fully occur. While the gold-standard is to treat with oral minocycline (100 mg daily), preliminary data suggests that topical minocycline may be effective as well. A case report of a 51-year-old female documents clearance with topical minocycline foam. Other antibiotics can be considered as well, such as azithromycin and erythromycin. Antifungal medications can also be considered as well as topicals such as tretinoin, tacrolimus, and urea.

Oral minocycline has a number of side effects and cannot be used in pregnancy. Given side effects and risks of lengthy oral antibiotic treatment, investigators believe that utilization of topical minocycline foam could be a suitable option for patients, especially those who do not want to be treated with oral minocycline for an extended period of time.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 9 years
  • Clinical diagnosis of CARP

Exclusion Criteria:

  • Current or recent (within 6 months) use of oral minocycline
  • Pregnancy or breastfeeding
  • History of intracranial hypertension, autoimmune disorder, liver/kidney disease
  • Immunocompromised status
  • Hypersensitivity to tetracyclines
  • Unstable medical condition
  • Inability or unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Half of the Body
Participants will apply the investigational topical medication to one half of the body that they choose
Drug: Topical Minocycline Foam FXFM244
Topical minocycline foam that will be applied to half of the subject's body that will be chosen by the subject.
Placebo Comparator: Control Half of the Body
Participants apply the control topical emollient without active ingredient to the contralateral half of the body
Other: Control
Control topical emollient that will be applied to the contralateral half of the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in analog score based on blinded reviewer analysis of individuals treated with both daily topical AMZEEQ® (minocycline) compared to topical emollient
Time Frame: 5 +/- 1 weeks
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.
5 +/- 1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess possible adverse effects secondary to topical minocycline (AMZEEQ) use
Time Frame: 6 +/- 1 weeks
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.
6 +/- 1 weeks
Discern patient satisfaction with daily topical minocycline (AMZEEQ) use compared to daily topical emollient
Time Frame: 6 +/- 1 weeks
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.
6 +/- 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Journey Medical Corporation

Investigators

  • Principal Investigator: Lara Wine Lee, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated (https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated)
  • FDA drug information, AMZEEQ®TM (minocycline) topical foam (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379s000lbl.pdf)
  • Lateef H, et al. Successful treatment of confluent and reticulated papillomatosis with minocycline topical 4% foam. SKIN. 2022; Vol 6. No. 1.
  • Nazarian S, Akhondi H. Minocycline. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. PMID: 32119406.
  • Le C, Bedocs PM. Confluent and Reticulated Papillomatosis. StatPearls [Internet]. Web. Last Updated: August 7, 2023. Accessed: July 20, 2024

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00140636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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