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.
Trial 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). Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Journey Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Lara Wine Lee, MD, Principal investigator, Medical University of South Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)
- ClinicalTrials.gov ID
- NCT07462702
- Acronym / sponsor ID
- Pro00140636
- Keywords
- Topical Minocycline, Confluent and reticulated papillomatosis (CARP), CARP, Confluent and reticulated papillomatosis, Minocycline, Tetracycline, Pruritus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Journey Medical Corporation
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Half of the Body | Experimental | Drug: Topical Minocycline Foam FXFM244Participants will apply the investigational topical medication to one half of the body that they choose |
| Control Half of the Body | Placebo comparator | Other: ControlParticipants apply the control topical emollient without active ingredient to the contralateral half of the body |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 9 years
- Clinical diagnosis of CARP
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Minocycline Foam FXFM244Topical minocycline foam that will be applied to half of the subject's body that will be chosen by the subject. | Drug | Experimental Half of the Body |
| ControlControl topical emollient that will be applied to the contralateral half of the body. | Other | Control Half of the Body |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- BackgroundFDA 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)
- BackgroundFDA drug information, AMZEEQ®TM (minocycline) topical foam (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379s000lbl.pdf)
- BackgroundLateef H, et al. Successful treatment of confluent and reticulated papillomatosis with minocycline topical 4% foam. SKIN. 2022; Vol 6. No. 1.
- BackgroundNazarian S, Akhondi H. Minocycline. 2023 Nov 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. PMID: 32119406.
- BackgroundLe C, Bedocs PM. Confluent and Reticulated Papillomatosis. StatPearls [Internet]. Web. Last Updated: August 7, 2023. Accessed: July 20, 2024
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lara Wine Lee, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462702, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.