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Cryotherapy Versus Steroids In Alopecia Areata:Trichoscopic Evaluation

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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

  Show Detailed Description

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



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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
Contact: Hanan Ahmed Morsy, Assistant professor 01064447881 Hanan_morsy2003@yahoo.com
Contact: Aya Youssef Mohamed, Lecturer 01013244819 Aya_badran@yahoo.com

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

Publications:

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
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