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

Not Applicable

Not yet recruiting

• Conditions: Alopecia Areata
• Interventions: Device: Fractional CO2 laser; Device: Derma pen; Drug: Niosome minoxidil; Drug: Minoxidil Topical Spray

• Registration Number: NCT05587257
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-16
• Last Update Submitted: 2022-10-16
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Study Start: 2023-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Fractional CO2 laser	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 2	Derma pen	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 3	Niosome minoxidil	15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.
Group 4	Minoxidil Topical Spray	15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months

Primary Outcome Measures

Name	Time	Method
Regrowth scale	6 months	0 score (regrowth \< 10%) no response; score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
Mcdonald Hull and Norris Regrowth Scale (by trichoscope	6 months	Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score.; Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia \> 75% in SALT score.