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

Assiut University

Status: Not yet enrolling

Conditions: Alopecia Areata

Treatments: Drug: Minoxidil Topical Spray; Device: Fractional CO2 laser; Drug: Niosome minoxidil; Device: Derma pen

Study type: Interventional

Funder types: Other

Identifiers

NCT05587257

Minoxidil in alopecia areata

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Group 1

Experimental group

Description:

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%

Treatment:

Device: Fractional CO2 laser

Group 2

Experimental group

Description:

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

Treatment:

Device: Derma pen

Group 3

Experimental group

Description:

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

Treatment:

Drug: Niosome minoxidil

Group 4

Active Comparator group

Description:

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

Treatment:

Drug: Minoxidil Topical Spray