Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata

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Brief Title

Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata

Official Title

Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata

Brief Summary

      Alopecia areata is a non-scarring hair loss disorder that affects both sexes equally.
      Incidence of the disease varies for different populations and in different studies, with
      global incidence ranging from 0.57% to 3.8%.

      Etiology of alopecia areata is not completely understood, and the majority of evidence
      suggests that genetically predisposed individuals, when exposed to an unknown trigger,
      develop a predominantly autoimmune reaction, leading to acute hair loss. Environmental
      triggers, including viral or bacterial infections, along with autoimmune disorders, seem to
      play a major role in the development of alopecia areata.
    

Detailed Description

      The onset and progression of alopecia areata are unpredictable. Significant variations in the
      clinical presentation of alopecia areata have been observed, ranging from small,
      well-circumscribed patches of hair loss to a complete absence of body and scalp hair.

      Although many patients improve spontaneously or respond to standard therapy, treatment can be
      quite challenging in those with more severe and refractory disease.

      Recent advances in the understanding of alopecia areata pathophysiology hold promise for
      better treatments in the future.

      Corticosteroids either topical or intralesional are the most popular drugs for the treatment
      of this disease. Other therapies like topical minoxidil, anthralin, immunotherapy, systemic
      corticosteroids, cyclosporine and Psoralen with Ultraviolet-A Light therapy are also commonly
      used with varying success.

      Various lasers have been suggested in recent studies to treat alopecia areata . The effect of
      308-nm excimer laser was the most studied, while others, including neodymium-doped yttrium
      aluminum garnet, erbium:glass laser, fractional carbon dioxide laser, and low-level laser
      therapy, have also been assessed.

      Despite the nascent state of research on lasers as a treatment option for alopecia areata ,
      there have been a great deal of promising results. It is possible for lasers to become the
      mainstay treatment option of alopecia areata .

      It was suggested that ablative fractional lasers may exert its effect through: induction of
      moderate inflammation to promote anagen entry and creation of channel pathways for topically
      applied medications they grant access to dermal structures such as hair follicles and
      cutaneous vasculature. Also, creation of a wound by the ablative fractional laser may
      stimulate stem cell populations to produce a hair shaft and progress through all stages of
      the hair follicle cycle.

      Majid et al, investigated the efficacy and safety of the combination of fractional carbon
      dioxide followed by topical triamcinolone acetonide application in ten patients with
      resistant alopecia areata. Only eight patients completed the study. Seven of them had
      complete recovery of the treated area. One patient however did not show good response. No
      significant adverse effects were noted in any of the patients.

      The role of platelet rich plasma in promoting hair survival and growth has been demonstrated
      both in vitro and in vivo. The activation of platelet α granules releases numerous growth
      factors, including transforming growth factor , platelet derived growth factor, vascular
      endothelial growth factor, epidermal growth factor, insulin-like growth factor, and
      interleukin-1. It is proposed that these growth factors may act on stem cells in the bulge
      area of the follicles, stimulating the development of new follicles and promoting
      neovascularization. platelet rich plasma has been found to benefit in hair growth in alopecia
      areata. Intralesional injections of platelet rich plasma were found to increase hair regrowth
      significantly compared with triamcinolone acetonide or placebo.

      Vitamin D 1, 25-dihydroxycholecalciferol [1, 25(OH)/2 D3] is the biologic active form of the
      vitamin D3. Vitamin D has a multitude of biologic effects interacting with the innate and
      adaptive immune system, mainly leading to its downregulation. It regulates the
      differentiation of B cells, T cells, dendritic cells, and the expression of Toll-like
      receptors. There is growing evidence that vitamin D may help in several autoimmune diseases
      like multiple sclerosis and type I diabetes mellitus, lupus, and rheumatoid arthritis.

      The relation between vitamin D levels and the development of alopecia areata and whether
      vitamin D supplementation helps in the treatment of alopecia areata represent an attractive
      area of research. Recent studies suggest that there is deficiency of serum vitamin D and
      reduced vitamin D receptor expression in the affected hair follicles in alopecia areata
      patients, the results of which may prove that vitamin D is a safe and helpful choice in
      alopecia areata treatment.

      To the best our knowledge no previous research studied the effect of vitamin D solution in
      treatment of alopecia areata.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

response rate


Condition

Alopecia Areata

Intervention

fractional carbon dioxide laser alone

Study Arms / Comparison Groups

 fractional carbon dioxide laser alone
Description:  six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata

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

Device

Estimated Enrollment

40

Start Date

July 26, 2019

Completion Date

July 1, 2022

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  patients with refractory alopecia areata above 10 years old

        Exclusion Criteria:

          -  Alopecia totalis or alopecia universalis.

          -  Patients with alopecia other than alopecia areata.

          -  Patients younger than 10 years.

          -  Pregnant and lactating females.

          -  Patients with history of hypertrophic scars or keloid formation.

          -  Patients with active infection at the site of the lesion.

          -  Patients with blood disorders and platelet abnormalities and chronic liver disease.

          -  Patients using anticoagulation therapy and antiplatelet agents.
      

Gender

All

Ages

10 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alaa Ghazally, MS, 01001801039, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04003376

Organization ID

CO2LASERAA


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

Alaa Ghazally, MS, Principal Investigator, Assiut University


Verification Date

May 2020