Confluent and Reticulated Papillomatosis (CARP)Early Phase 1NCT07462702

Topical Minocycline for CARP

A Early Phase 1 study testing Topical Minocycline Foam FXFM244 in people with Confluent and Reticulated Papillomatosis (CARP), run by Medical University of South Carolina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 9 years and older
Conditions the study is for: Confluent and Reticulated Papillomatosis (CARP)
What is being tested?: Topical Minocycline Foam FXFM244
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: No sites listed yet
Study dates: 15 Dec 2026to Feb 2028
Phase: Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age ≥ 9 years
Clinical diagnosis of CARP

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Conditions: Confluent and Reticulated Papillomatosis (CARP)
Being tested: Topical Minocycline Foam FXFM244, Control
Keywords: Topical Minocycline, Confluent and reticulated papillomatosis (CARP), CARP, Confluent and reticulated papillomatosis, Minocycline, Tetracycline, Pruritus
Medical subject headings: Papillomatosis, Familial Cutaneous, cyclopia sequence, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical Minocycline Foam FXFM244Drug
Topical minocycline foam that will be applied to half of the subject's body that will be chosen by the subject.
ControlOther
Control topical emollient that will be applied to the contralateral half of the body.

Study groups in NCT07462702
Study group	Role	What they receive
Experimental Half of the Body	Experimental	Participants will apply the investigational topical medication to one half of the body that they choose Receives: 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 Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 +/- 1 weeks

Secondary outcomes (2)

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.
Measured: 6 +/- 1 weeks
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.
Measured: 6 +/- 1 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 2026Feb 2028

First posted10 Mar 2026
Study start15 Dec 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionFeb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Confluent and Reticulated Papillomatosis (CARP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 35 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07462702
Sponsor's protocol ID: Pro00140636
Status last verified: Oct 2026
First submitted: 12 Feb 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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