Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

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Brief Title

Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

Official Title

Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation

Brief Summary

      Alopecia areata is the most frequent cause of inflammation-induced hair loss with prevalence
      from 0.1 to 0.2%. It has no age nor sex predilection .

      Clinically, alopecia areata presents as a well-circumscribed patch of sudden hair loss. It
      affects any hair bearing area. The most common affected site is the scalp. Based on site and
      extent, AA can be classified into; diffuse, multi-locularis, mono-locularis, totalis,
      universalis, and ophiasis.
    

Detailed Description

      Histologically, lesional biopsies of alopecia areata demonstrate a peri_follicullare and
      intra_folliculare mononuclear cell infiltrate around anagen phase hair follicles .The
      infiltrate consists mostly of activated lymphocytes in particular CD4 cells as well as
      dendritic cells and macrophages.

      Many theories were implicated in pathogenesis of alopecia areata such as; autoimmune
      lymphocytic attack of the hair, genetic basis and environmental factors. So the pathogenesis
      of alopecia areata remains to be determined. Currently a widely accepted theory is the
      autoimmune etiology. Specific T_cell lymphocytes, autoantibodies against anagen follicles,
      and various cytokines such as interferon-γ, interleukins, and tumor necrosis factor-α have
      been found to play a major role in alopecia areata. In addition, the immune privilege theory
      has been recently introduced and suggested to play a role in the pathogenesis.

      Many kinds of treatment modalities are present in localized alopecia areata. Injectable forms
      of corticosteroids are first line of alopecia areata therapy, and also topical use of
      steroids is widely used. Others are topical sensitization with anthrain, minoxidil and
      cryotherapy. In extention form of alopecia areata, systemic treatments like corticosteroids,
      cyclosporine and methotrexate can be used.

      Intralesional Corticosteroid injection:

      National Guidelines from British Association of Dermatologists, recommend intralesional
      corticosteroid therapy as the first line treatment for localized patchy alopecia areata, with
      approximate success rates of 60-75%. Their use was first described in 1958, with the use of
      hydrocortisone.

      Immunosuppression is the main mechanism of action. Corticosteroids suppress the
      T-cell-mediated immune attack on the hair follicle. Steroids with low solubility are
      preferred for their slow absorption from the injection site, promoting maximum local action
      with minimal systemic effect. The efficacy of intralesional corticosteroid injection is
      variable depending on the patient population treated.

      Cryotherapy:

      Cryotherapy may act through either singly or by a combination of the following mechanisms
      resulting in hair regrowth in alopecia areata. After initial vasoconstriction with
      cryotherapy, there is a significant local vasodilatation during the thaw period as the
      temperature reaches zero degree Celsius. Thus, cryotherapy is speculated to dilate the
      vessels around the affected hair follicles, with an increase in the blood flow leading to
      follicular hair regrowth. Moreover, local edema and inflammation occurring after cryotherapy
      may play a role in inducing vasodilation.

      Cryotherapy is also speculated to inflict partial damage to keratinocytes, especially the
      antigenic components of the hair follicle keratin16 and trichohyalin, which are targeted by
      antibodies and thus, further decrease in damaging perifollicular infiltrate.

      Cryotherapy may also alter tissue Langerhans cells, which in turn could alter the process of
      antigen presentation with further decrease in T cell infiltration. As it is known, the white
      hairs are spared in alopecia areata; it is hypothesized that melanocytes may have a role in
      the pathogenesis ofalopecia areata. Hence, cryotherapy may also act by destructing the
      melanocytes further preventing their role in the initiation of alopecia areata.

      Dermoscopy:

      Dermoscopy is now considered as a valuable tool in diagnosis of variable skin lesions. It is
      a non-invasive procedure which was initially used to assess pigmented lesions.

      Scalp dermoscopy (Trichoscopy) does not only facilitate diagnosis of hair disorders but also
      give clues about disease stage and progression. Trichoscopy allows the superimposition of the
      skin layers with the possibility to observe any surface or deep skin layers.

      The most common trichoscopic features of alopecia areata are yellow dots, micro-exclamation
      mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing
      coiled hairs. Black dots as remnants of exclamation mark hairs or broken hairs provide a
      sensitive marker for disease activity as well as severity of alopecia areata. Yellow dots,
      are considered to be the most sensitive dermoscopic feature of alopecia areata. Tapering hair
      is considered as a marker of disease activity and known to reflect exacerbation of disease.
      Trichoscopic characteristics have a clinical significance in alopecia areata for diagnosis
      and prognosis.

      Severity of alopecia tool Score:

      National Alopecia Areata Foundation working committee has devised "Severity of Alopecia Tool
      score. Severity of alopecia tool score is useful to find out the quantitative assessment of
      scalp hair loss.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

The incidence of patietns with hair regrowth


Condition

Alopecia Areata

Intervention

Cryotherapy

Study Arms / Comparison Groups

 study group
Description:  •The first group (20 patients) will be treated with cryotherapy using liquid nitrogen spray, two cycles each one 3-5 seconds, one session every two weeks, for three months.

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

Procedure

Estimated Enrollment

40

Start Date

November 2018

Completion Date

September 2019

Primary Completion Date

July 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Age >12 years.

          -  Both sexes will be included.

          -  Newly diagnosed cases.

        Exclusion Criteria:

          -  Children < 12 years.

          -  Pregnancy and lactation.

          -  Patients with active scalp infection.

          -  Patients with cold sensitivity (regarding the first group).

          -  Any newly onset medical systemic illness.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 01064447881, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03473600

Organization ID

CVILCsAA


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

March 2018