Topical Minocycline for CARP

NCT07462702 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: Pro00140636
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Confluent and Reticulated Papillomatosis (CARP)

Keywords

Topical Minocycline; Confluent and reticulated papillomatosis (CARP); CARP; Confluent and reticulated papillomatosis; Minocycline; Tetracycline; Pruritus

Outcome Measures

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.

  5 +/- 1 weeks

Secondary Outcomes (2)

• Assess possible adverse effects secondary to topical minocycline (AMZEEQ) use

  6 +/- 1 weeks

• Discern patient satisfaction with daily topical minocycline (AMZEEQ) use compared to daily topical emollient

  6 +/- 1 weeks

Study Arms (2)

Experimental Half of the Body

EXPERIMENTAL

Participants will apply the investigational topical medication to one half of the body that they choose

Drug: Topical Minocycline Foam FXFM244

Control Half of the Body

PLACEBO COMPARATOR

Participants apply the control topical emollient without active ingredient to the contralateral half of the body

Other: Control

Interventions

Control OTHER

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

Control Half of the Body

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.

Experimental Half of the Body

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 9 years
• Clinical diagnosis of CARP

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Journey Medical Corporation: collaborator

Related Publications (5)

• 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)

  BACKGROUND

• FDA drug information, AMZEEQ®TM (minocycline) topical foam (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379s000lbl.pdf)

  BACKGROUND

• Lateef H, et al. Successful treatment of confluent and reticulated papillomatosis with minocycline topical 4% foam. SKIN. 2022; Vol 6. No. 1.

  BACKGROUND

• Nazarian S, Akhondi H. Minocycline. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. PMID: 32119406.

  BACKGROUND

• Le C, Bedocs PM. Confluent and Reticulated Papillomatosis. StatPearls [Internet]. Web. Last Updated: August 7, 2023. Accessed: July 20, 2024

  BACKGROUND

MeSH Terms

Conditions

Papillomatosis, Familial Cutaneous; cyclopia sequence; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lara Wine Lee, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share