Topical Minocycline for CARP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Minocycline Foam FXFM244, Control.
- Who it may be relevant to
- Registry conditions: Confluent and Reticulated Papillomatosis (CARP). Basic parameters: from 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)
Overview
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.
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.
Interventions
- 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. - Other Control
Control topical emollient that will be applied to the contralateral half of the body.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Assess possible adverse effects secondary to topical minocycline (AMZEEQ) use [Time frame: 6 +/- 1 weeks]
- Discern patient satisfaction with daily topical minocycline (AMZEEQ) use compared to daily topical emollient [Time frame: 6 +/- 1 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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
Identifiers
NCT: NCT07462702 · Pro00140636