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Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Cryotherapy
Triamcinolone acetonide injection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

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

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.

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm 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.

•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.

Outcomes

Primary Outcome Measures

The incidence of patietns with hair regrowth
measuring severity of alopecia tool score and dermoscopic examination

Secondary Outcome Measures

Full Information

First Posted
March 15, 2018
Last Updated
March 21, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03473600
Brief Title
Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation
Official Title
Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
•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.
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
Liquid Nitrogen spray
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide injection
Intervention Description
Intralesional Triamcinolone Acetonide injection
Primary Outcome Measure Information:
Title
The incidence of patietns with hair regrowth
Description
measuring severity of alopecia tool score and dermoscopic examination
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Ahmed Morsy, Assistant professor
Phone
01064447881
Email
Hanan_morsy2003@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Youssef Mohamed, Lecturer
Phone
01013244819
Email
Aya_badran@yahoo.com
Facility Information:
Facility Name
Faculty of medicine
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya Youssef, Lecturer
Phone
01013244819

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20115945
Citation
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010 Feb;62(2):177-88, quiz 189-90. doi: 10.1016/j.jaad.2009.10.032.
Results Reference
background
PubMed Identifier
18613881
Citation
Campos-do-Carmo G, Ramos-e-Silva M. Dermoscopy: basic concepts. Int J Dermatol. 2008 Jul;47(7):712-9. doi: 10.1111/j.1365-4632.2008.03556.x.
Results Reference
background
PubMed Identifier
19852119
Citation
Chang KH, Rojhirunsakool S, Goldberg LJ. Treatment of severe alopecia areata with intralesional steroid injections. J Drugs Dermatol. 2009 Oct;8(10):909-12.
Results Reference
background
PubMed Identifier
22512484
Citation
Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012 Apr 19;366(16):1515-25. doi: 10.1056/NEJMra1103442. No abstract available.
Results Reference
background
PubMed Identifier
17671634
Citation
Gilhar A, Paus R, Kalish RS. Lymphocytes, neuropeptides, and genes involved in alopecia areata. J Clin Invest. 2007 Aug;117(8):2019-27. doi: 10.1172/JCI31942.
Results Reference
background
PubMed Identifier
20300578
Citation
Gregoriou S, Papafragkaki D, Kontochristopoulos G, Rallis E, Kalogeromitros D, Rigopoulos D. Cytokines and other mediators in alopecia areata. Mediators Inflamm. 2010;2010:928030. doi: 10.1155/2010/928030. Epub 2010 Mar 11.
Results Reference
background
PubMed Identifier
18799878
Citation
Inui S, Nakajima T, Itami S. Significance of dermoscopy in acute diffuse and total alopecia of the female scalp: review of twenty cases. Dermatology. 2008;217(4):333-6. doi: 10.1159/000155644. Epub 2008 Sep 18.
Results Reference
background
PubMed Identifier
13610145
Citation
KALKOFF KW, MACHER E. [Growing of hair in alopecia areata & maligna after intracutaneous hydrocortisone injection]. Hautarzt. 1958 Oct;9(10):441-51. No abstract available. German.
Results Reference
background
PubMed Identifier
20613773
Citation
Kang H, Wu WY, Lo BK, Yu M, Leung G, Shapiro J, McElwee KJ. Hair follicles from alopecia areata patients exhibit alterations in immune privilege-associated gene expression in advance of hair loss. J Invest Dermatol. 2010 Nov;130(11):2677-80. doi: 10.1038/jid.2010.180. Epub 2010 Jul 8. No abstract available.
Results Reference
background
PubMed Identifier
10727299
Citation
Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.
Results Reference
background
PubMed Identifier
21965849
Citation
Mane M, Nath AK, Thappa DM. Utility of dermoscopy in alopecia areata. Indian J Dermatol. 2011 Jul;56(4):407-11. doi: 10.4103/0019-5154.84768.
Results Reference
background
PubMed Identifier
15337988
Citation
Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.
Results Reference
background
PubMed Identifier
24937813
Citation
Pimentel CB, Moraes AM, Cintra ML. Angiogenic effects of cryosurgery with liquid nitrogen on the normal skin of rats, through morphometric study. An Bras Dermatol. 2014 May-Jun;89(3):410-3. doi: 10.1590/abd1806-4841.20142249.
Results Reference
background
PubMed Identifier
18329131
Citation
Rodriguez TA, Duvic M; National Alopecia Areata Registry. Onset of alopecia areata after Epstein-Barr virus infectious mononucleosis. J Am Acad Dermatol. 2008 Jul;59(1):137-9. doi: 10.1016/j.jaad.2008.02.005. Epub 2008 Mar 7.
Results Reference
background
PubMed Identifier
22408709
Citation
Rudnicka L, Olszewska M, Rakowska A, Slowinska M. Trichoscopy update 2011. J Dermatol Case Rep. 2011 Dec 12;5(4):82-8. doi: 10.3315/jdcr.2011.1083.
Results Reference
background
PubMed Identifier
7738385
Citation
Sawaya ME, Hordinsky MK. Glucocorticoid regulation of hair growth in alopecia areata. J Invest Dermatol. 1995 May;104(5 Suppl):30S. doi: 10.1038/jid.1995.49. No abstract available.
Results Reference
background
PubMed Identifier
23974575
Citation
Seetharam KA. Alopecia areata: an update. Indian J Dermatol Venereol Leprol. 2013 Sep-Oct;79(5):563-75. doi: 10.4103/0378-6323.116725.
Results Reference
background
PubMed Identifier
24326551
Citation
Shapiro J. Current treatment of alopecia areata. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S42-4. doi: 10.1038/jidsymp.2013.14.
Results Reference
background
PubMed Identifier
17062039
Citation
Tosti A, Iorizzo M, Botta GL, Milani M. Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trial. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1243-7. doi: 10.1111/j.1468-3083.2006.01781.x.
Results Reference
background
PubMed Identifier
17269961
Citation
Wasserman D, Guzman-Sanchez DA, Scott K, McMichael A. Alopecia areata. Int J Dermatol. 2007 Feb;46(2):121-31. doi: 10.1111/j.1365-4632.2007.03193.x.
Results Reference
background

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Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

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