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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05587257
• Other study ID #: Minoxidil in alopecia areata
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Ahmed Elsayed, Master
• Phone: +20 1000520295
• Email: Ahmed.alsaid[@]med.aun.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Device:
• 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
• 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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regrowth scale	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	6 months
Primary	Mcdonald Hull and Norris Regrowth Scale (by trichoscope	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.	6 months