Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata

NCT ID: NCT05587257

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-02-01

Brief Summary

• Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.
• Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.

Detailed Description

Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).

Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).

Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).

Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).

In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).

The combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020).

To the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%

Group Type: EXPERIMENTAL

Fractional CO2 laser

Intervention Type: DEVICE

Each patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied.

All patients will advised not to use any other treatment during the study

Group 2

six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%

Group Type: EXPERIMENTAL

Derma pen

Intervention Type: DEVICE

, will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart.

Group 3

15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.

Group Type: EXPERIMENTAL

Niosome minoxidil

Intervention Type: DRUG

The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.

Group 4

15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months

Group Type: ACTIVE_COMPARATOR

Minoxidil Topical Spray

Intervention Type: DRUG

The patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment.

Interventions

Fractional CO2 laser

Each patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied.

All patients will advised not to use any other treatment during the study

Intervention Type: DEVICE

Derma pen

, will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart.

Intervention Type: DEVICE

Niosome minoxidil

The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.

Intervention Type: DRUG

Minoxidil Topical Spray

The patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment.

Intervention Type: DRUG

Other Intervention Names

Drug; Drug

Eligibility Criteria

Inclusion Criteria

• The study will include patients with alopecia areata

Exclusion Criteria

• Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.

patient recieved any treatment for alopecia areata in the last 3 months before the study.

patients with extensive types (alopecia totalis, universalis and surface area >50%).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elsayed Mohamed

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Elsayed, Master

Role: CONTACT

Ahmed.alsaid@med.aun.eg

+20 1000520295

Other Identifiers

Minoxidil in alopecia areata

Identifier Type: -

Identifier Source: org_study_id