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

NCT ID: NCT04147845

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2020-11-27

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.

Detailed Description

Alopecia areata (AA) is one of the most common forms of non-scarring alopecia involving the scalp and/or body. Estimated incidence of alopecia areata is 20.9 per 100,000 person-years with a cumulative lifetime incidence of 2.1%.

The exact pathophysiology of alopecia areata remains unknown. The most widely accepted hypothesis is that alopecia areata is a T cell-mediated autoimmune condition that is most likely to occur in genetically predisposed individuals.

Although, alopecia areata is a benign condition and most patients are asymptomatic, it can cause emotional and psychosocial distress in affected individuals.

First-line therapies include intralesional corticosteroids, topical corticosteroids, minoxidil, anthralin, topical immunotherapy, prostaglandin analogues, topical retinoids bexarotene, and capsaicin. Second- and third-line treatments include topical and systemic immunomodulatory therapies such as oral and topical psoralen plus UVA radiation and photodynamic therapy.No treatment is either curative or preventive. Since no single treatment option is certain to treat alopecia areata, the need for new therapies is mounting.

Intralesional corticosteroids, most commonly triamcinolone acetonide are considered a first-line treatment method for limited disease and can be used as adjunctive therapy in extensive disease. Because triamcinolone is only emulsified temporally to the water, usually it is delivered by the painful intralesional injection.

Platelet-rich plasma (PRP) has emerged as a new treatment modality in dermatology, and preliminary evidence has suggested that it might have a beneficial role in hair growth.

Drugs applied topically have the advantage of fewer side effects, and bypassing the first-pass effect. However, transepidermal dermal drug delivery has limitations, including decreased penetration of larger and water-soluble molecules.

Several strategies have been used to improve many drug penetrations into the skin: microneedling, ultrasound, and more recently transepidermal drug delivery (TED). TED is a technique based on applying a medication following an ablative method (CO2 laser, erbium lasers or ablative radiofrequency), which create vertical channels to assist the delivery of topically applied drugs into the skin. The use of nonablative lasers as well as microneedling technique has been reported with the same purpose.

Fractional laser-assisted drug delivery of corticosteroids for resistant alopecia areata is a new concept in dermatological therapy.

Microneedle devices, such as Dermaroller and Dermapen, are minimally invasive devices that bypass the stratum corneum barrier, thus accessing the skin microcirculation and achieving systemic delivery by the transepidermal route.

Trichoscopy, hair and scalp dermoscopy, is a fast, non-invasive method useful in the diagnosis and therapeutic monitoring of scalp and hair diseases.

Conditions

Alopecia Areata

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional Carbon dioxide laser and triamcinolone acetonide

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

Group Type: EXPERIMENTAL

Fractional Carbon Dioxide Laser

Intervention Type: 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

Triamcinolone Acetonide

Intervention Type: OTHER

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

Microneedling with Dermapen and triamcinolone acetonide

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

Group Type: EXPERIMENTAL

Microneedling using dermapen

Intervention Type: 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.

Triamcinolone Acetonide

Intervention Type: OTHER

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

Fractional Carbon dioxide laser and Platelet-rich plasma

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

Group Type: EXPERIMENTAL

Fractional Carbon Dioxide Laser

Intervention Type: 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

Platelet-rich plasma

Intervention Type: OTHER

The applied PRP will be spread over the whole affected area

Microneedling with Dermapen and Platelet-rich plasma

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

Group Type: EXPERIMENTAL

Microneedling using dermapen

Intervention Type: 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.

Platelet-rich plasma

Intervention Type: OTHER

The applied PRP will be spread over the whole affected area

Interventions

Fractional Carbon Dioxide Laser

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

Intervention Type: OTHER

Microneedling using dermapen

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.

Intervention Type: OTHER

Triamcinolone Acetonide

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

Intervention Type: OTHER

Platelet-rich plasma

The applied PRP will be spread over the whole affected area

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with alopecia areata of either gender, diagnosed both clinically and by trichoscopy

2. Patients not responding to treatment (topical and/or systemic), used properly and regularly, for at least 3 months duration

Exclusion Criteria

1. Alopecia areata with evidence of spontaneous hair regrowth

2. Patients having active scalp inflammation or other scalp or hair diseases

3. Pregnant and lactating women

4. Patients with any bleeding disorder or receiving anti-coagulant therapy

5. Immunocompromised patients

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Ibrahim Halwag

Assistant Lecturer of Dermatology, Venereology and Andrology . Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled El Mulla, MBBCh, MS, Ph.D

Role: STUDY_DIRECTOR

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

Eman Elmorsy, MBBCh, MS, Ph.D

Role: STUDY_DIRECTOR

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

Locations

Faculty of Medicine, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

AlexandriaU Derma

Identifier Type: -

Identifier Source: org_study_id