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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional Carbon Dioxide Laser
Microneedling using dermapen
Triamcinolone Acetonide
Platelet-rich plasma
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Transepidermal drug delivery, Fractional Carbon Dioxide Laser, Platelet-Rich Plasma, Microneedling, Triamcinolone acetonide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Fractional Carbon dioxide laser and triamcinolone acetonide

Microneedling with Dermapen and triamcinolone acetonide

Fractional Carbon dioxide laser and Platelet-rich plasma

Microneedling with Dermapen and Platelet-rich plasma

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 26, 2019
Last Updated
December 6, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04147845
Brief Title
Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata
Official Title
Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, Transepidermal drug delivery, Fractional Carbon Dioxide Laser, Platelet-Rich Plasma, Microneedling, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional Carbon dioxide laser and triamcinolone acetonide
Arm Type
Experimental
Arm Description
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
Arm Title
Microneedling with Dermapen and triamcinolone acetonide
Arm Type
Experimental
Arm Description
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
Arm Title
Fractional Carbon dioxide laser and Platelet-rich plasma
Arm Type
Experimental
Arm Description
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
Arm Title
Microneedling with Dermapen and Platelet-rich plasma
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Fractional Carbon Dioxide Laser
Intervention Description
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
Intervention Name(s)
Microneedling using dermapen
Intervention Description
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
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
triamcinolone solution (10 mg/ml) will be dropped on the treated area and spread evenly
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma
Intervention Description
The applied PRP will be spread over the whole affected area
Primary Outcome Measure Information:
Title
Clinical evaluation of hair regrowth
Description
Each patch will be digitally macrophotographed, and evaluated clinically at baseline and at the end of the treatment sessions, for signs of hair regrowth
Time Frame
Three months
Title
Dermoscopic evaluation of hair regrowth
Description
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
Time Frame
Three months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled El Mulla, MBBCh, MS, Ph.D
Organizational Affiliation
Professor of Dermatology,Venereology and Andrology, Faculty of Medicine, University of Alexandria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eman Elmorsy, MBBCh, MS, Ph.D
Organizational Affiliation
Professor of Dermatology,Venereology and Andrology, Faculty of Medicine, University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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