Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473600
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Noura Ali, Assiut University

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.


Condition or disease Intervention/treatment Phase
Alopecia Areata Procedure: Cryotherapy Drug: Triamcinolone acetonide injection Phase 4

  Hide Detailed Description

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: study group
•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.
Procedure: Cryotherapy
Liquid Nitrogen spray

Active Comparator: control group
•The second group (20 patients) will be treated with intralesional injection of 4mg/ml/ session of triamcinolone-acetonide, it will be injected into deep dermis or upper subcutaneous tissue using a 0.5-inch long 30-gauge needle at multiple sites, 1 cm apart and 0.1 ml into each site, once every three weeks, for three months, using insulin syringes.
Drug: Triamcinolone acetonide injection
Intralesional Triamcinolone Acetonide injection




Primary Outcome Measures :
  1. The incidence of patietns with hair regrowth [ Time Frame: 3 months ]
    measuring severity of alopecia tool score and dermoscopic examination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473600


Contacts
Layout table for location contacts
Contact: Hanan Ahmed Morsy, Assistant professor 01064447881 Hanan_morsy2003@yahoo.com
Contact: Aya Youssef Mohamed, Lecturer 01013244819 Aya_badran@yahoo.com

Locations
Layout table for location information
Egypt
Faculty of medicine Not yet recruiting
Assiut, Egypt, 71111
Contact: Aya Youssef, Lecturer    01013244819      
Sponsors and Collaborators
Assiut University

Publications:

Layout table for additonal information
Responsible Party: Noura Ali, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03473600     History of Changes
Other Study ID Numbers: CVILCsAA
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hair Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action