Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Journey Medical Corporation | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Half of the Body | Experimental | Participants will apply the investigational topical medication to one half of the body that they choose |
|
| Control Half of the Body | Placebo Comparator | Participants apply the control topical emollient without active ingredient to the contralateral half of the body |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lara Wine Lee, MD | Medical University of South Carolina | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C566832 | Papillomatosis, Familial Cutaneous |
| C562573 | cyclopia sequence |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Other | Control topical emollient that will be applied to the contralateral half of the body. |
|
| 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. | 6 +/- 1 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |