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

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

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Device: Fractional CO2 laser; Device: Derma pen; Drug: Niosome minoxidil; Drug: Minoxidil Topical Spray

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elsayed, Master; Phone Number: +20 1000520295; Email: Ahmed.alsaid@med.aun.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%	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; Other Names: Drug
Experimental: 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%	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.; Other Names: Drug
Experimental: Group 3; 15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.	Drug: Niosome minoxidil; The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.
Active Comparator: Group 4; 15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: Minoxidil in alopecia areata

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No