Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata

NCT04147845 | Completed

• 1 other identifier: AlexandriaU Derma
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the use of fractional carbon dioxide laser versus microneedling in the transepidermal delivery of triamcinolone acetonide and platelet rich plasma in treatment of alopecia areata.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Transepidermal drug delivery; Fractional Carbon Dioxide Laser; Platelet-Rich Plasma; Microneedling; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (2)

• Clinical evaluation of hair regrowth

  Each patch will be digitally macrophotographed, and evaluated clinically at baseline and at the end of the treatment sessions, for signs of hair regrowth

  Three months

• Dermoscopic evaluation of hair regrowth

  Each patch will be digitally macrophotographed, and evaluated by dermoscopy at baseline and at the end of the treatment sessions, for signs of hair regrowth

  Three months

Study Arms (4)

Fractional Carbon dioxide laser and triamcinolone acetonide

EXPERIMENTAL

Group I:Fractional Carbon dioxide laser (CO2 Laser) and triamcinolone acetonide (TrA; 10 mg/ ml) (14, 15) The ablative fractional CO2 laser is delivered to the patients' scalp. The fractional ablative method is applied immediately before the topcial medication. Laser treatment will be given to the affected area, and immediately after the treatment, triamcinolone solution (10 mg/ml) will be dropped on the treated area and spread evenly. Each patient will receive four treatments, with an interval of three weeks between the treatment sessions, for a total of 12 weeks.This will be followed by a follow up period of another 4 weeks. The patients will be given no topical treatments for the alopecia areata in between the sessions. Topical post-procedure care in the form of topical antibiotics, emollient or sunscreen may be used. Each patch will be digitally macrophotographed, and evaluated clinically and by dermoscopy at baseline and at the end of the study, for signs of hair regrowth

Other: Fractional Carbon Dioxide Laser; Other: Triamcinolone Acetonide

Microneedling with Dermapen and triamcinolone acetonide

EXPERIMENTAL

Microneedling is performed using Dermapen. This creates pin point bleeding or mild erythema which will be considered as the end point. Triamcinolone acetonide in concentration of 10 mg/ml (0.1 ml containing 1 mg of triamcinolone) will be applied on each lesion twice, before and after performing microneedling. Each patient will receive four treatments, with an interval of three weeks between the treatment sessions, for a total of 12 weeks.This will be followed by a follow up period of another 4 weeks. The patients will be given no topical treatments for the alopecia areata in between the sessions. Topical post-procedure care in the form of topical antibiotics, emollient or sunscreen may be used. Each patch will be digitally macrophotographed, and evaluated clinically and by dermoscopy at baseline and at the end of the study, for signs of hair regrowth

Other: Microneedling using dermapen; Other: Triamcinolone Acetonide

Fractional Carbon dioxide laser and Platelet-rich plasma

EXPERIMENTAL

The same laser parameters as group I will be used, followed by application of freshly prepared PRP. The applied PRP will be spread over the whole affected area. Each patient will receive four treatments, with an interval of three weeks between the treatment sessions, for a total of 12 weeks.This will be followed by a follow up period of another 4 weeks. The patients will be given no topical treatments for the alopecia areata in between the sessions. Topical post-procedure care in the form of topical antibiotics, emollient or sunscreen may be used. Each patch will be digitally macrophotographed, and evaluated clinically and by dermoscopy at baseline and at the end of the study, for signs of hair regrowth

Other: Fractional Carbon Dioxide Laser; Other: Platelet-rich plasma

Microneedling with Dermapen and Platelet-rich plasma

EXPERIMENTAL

Microneedling using dermapen is performed as Group II. Microneedling is preceeded and followed by intermittent application of freshly prepared PRP. The applied PRP will be spread over the whole affected area and again rolled till pinpoint bleeding points are noticed. Each patient will receive four treatments, with an interval of three weeks between the treatment sessions, for a total of 12 weeks.This will be followed by a follow up period of another 4 weeks. The patients will be given no topical treatments for the alopecia areata in between the sessions. Topical post-procedure care in the form of topical antibiotics, emollient or sunscreen may be used. Each patch will be digitally macrophotographed, and evaluated clinically and by dermoscopy at baseline and at the end of the study, for signs of hair regrowth

Other: Microneedling using dermapen; Other: Platelet-rich plasma

Interventions

Fractional Carbon Dioxide Laser OTHER

The ablative fractional CO2 laser is delivered to the patients' scalp. The fractional ablative method is applied immediately before the topcial medication. Laser treatment will be given to the affected area, and immediately after the treatment, the treatment solution will be dropped on the treated area and spread evenly

Fractional Carbon dioxide laser and Platelet-rich plasma; Fractional Carbon dioxide laser and triamcinolone acetonide

Microneedling using dermapen OTHER

Microneedling is performed using Dermapen. This creates pin point bleeding or mild erythema which will be considered as the end point. The treatment solution will be applied on each lesion twice, before and after performing microneedling.

Microneedling with Dermapen and Platelet-rich plasma; Microneedling with Dermapen and triamcinolone acetonide

Triamcinolone Acetonide OTHER

triamcinolone solution (10 mg/ml) will be dropped on the treated area and spread evenly

Fractional Carbon dioxide laser and triamcinolone acetonide; Microneedling with Dermapen and triamcinolone acetonide

Platelet-rich plasma OTHER

The applied PRP will be spread over the whole affected area

Fractional Carbon dioxide laser and Platelet-rich plasma; Microneedling with Dermapen and Platelet-rich plasma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with alopecia areata of either gender, diagnosed both clinically and by trichoscopy
• Patients not responding to treatment (topical and/or systemic), used properly and regularly, for at least 3 months duration

You may not qualify if:

• Alopecia areata with evidence of spontaneous hair regrowth
• Patients having active scalp inflammation or other scalp or hair diseases
• Pregnant and lactating women
• Patients with any bleeding disorder or receiving anti-coagulant therapy
• Immunocompromised patients

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Khaled El Mulla, MBBCh, MS, Ph.D

  Professor of Dermatology,Venereology and Andrology, Faculty of Medicine, University of Alexandria

  STUDY DIRECTOR

• Eman Elmorsy, MBBCh, MS, Ph.D

  Professor of Dermatology,Venereology and Andrology, Faculty of Medicine, University of Alexandria

  STUDY DIRECTOR

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 of Dermatology, Venereology and Andrology . Principal Investigator

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: November 1, 2019
• Study Start: October 30, 2019
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)