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

NCT05587257 | Unknown

• 1 other identifier: Minoxidil in alopecia areata
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Drug: Niosome minoxidil

Group 4

ACTIVE COMPARATOR

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

Drug: Minoxidil Topical Spray

Interventions

Fractional CO2 laser 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

Also known as: Drug

Group 1

Derma pen 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.

Also known as: Drug

Group 2

Niosome minoxidil DRUG

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

Group 3

Minoxidil Topical Spray DRUG

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

Group 4

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The study will include patients with alopecia areata

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Alopecia Areata

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Ahmed Elsayed, Master

CONTACT

+20 1000520295; Ahmed.alsaid@med.aun.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share