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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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

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.
    


Study Type

Interventional


Primary Outcome

Clinical evaluation of hair regrowth


Condition

Alopecia Areata

Intervention

Fractional Carbon Dioxide Laser

Study Arms / Comparison Groups

 Fractional Carbon dioxide laser and triamcinolone acetonide
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

October 30, 2019

Completion Date

October 2020

Primary Completion Date

October 2020

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Khaled El Mulla, MBBCh, MS, Ph.D, 00201224489473, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04147845

Organization ID

AlexandriaU Derma


Responsible Party

Principal Investigator

Study Sponsor

Alexandria University


Study Sponsor

Khaled El Mulla, MBBCh, MS, Ph.D, Study Director, Professor of Dermatology,Venereology and Andrology, Faculty of Medicine, University of Alexandria


Verification Date

January 2020