NCT03473600

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 15, 2018

Last Update Submit

March 21, 2018

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • The incidence of patietns with hair regrowth

    measuring severity of alopecia tool score and dermoscopic examination

    3 months

Study Arms (2)

study group

EXPERIMENTAL

•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

control group

ACTIVE COMPARATOR

•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

Interventions

CryotherapyPROCEDURE

Liquid Nitrogen spray

study group
Triamcinolone acetonide injectionDRUG

Intralesional Triamcinolone Acetonide injection

control group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>12 years.
  • Both sexes will be included.
  • Newly diagnosed cases.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71111, Egypt

Location

Related Publications (20)

  • 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.

    PMID: 20115945BACKGROUND

  • 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.

    PMID: 18613881BACKGROUND

  • Chang KH, Rojhirunsakool S, Goldberg LJ. Treatment of severe alopecia areata with intralesional steroid injections. J Drugs Dermatol. 2009 Oct;8(10):909-12.

    PMID: 19852119BACKGROUND

  • 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.

    PMID: 22512484BACKGROUND

  • 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.

    PMID: 17671634BACKGROUND

  • 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.

    PMID: 20300578BACKGROUND

  • 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.

    PMID: 18799878BACKGROUND

  • 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.

    PMID: 13610145BACKGROUND

  • 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.

    PMID: 20613773BACKGROUND

  • Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.

    PMID: 10727299BACKGROUND

  • 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.

    PMID: 21965849BACKGROUND

  • 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.

    PMID: 15337988BACKGROUND

  • 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.

    PMID: 24937813BACKGROUND

  • 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.

    PMID: 18329131BACKGROUND

  • 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.

    PMID: 22408709BACKGROUND

  • 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.

    PMID: 7738385BACKGROUND

  • Seetharam KA. Alopecia areata: an update. Indian J Dermatol Venereol Leprol. 2013 Sep-Oct;79(5):563-75. doi: 10.4103/0378-6323.116725.

    PMID: 23974575BACKGROUND

  • Shapiro J. Current treatment of alopecia areata. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S42-4. doi: 10.1038/jidsymp.2013.14.

    PMID: 24326551BACKGROUND

  • 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.

    PMID: 17062039BACKGROUND

  • 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.

    PMID: 17269961BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

CryotherapyTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Hanan Ahmed Morsy, Assistant professor

CONTACT

01064447881Hanan_morsy2003@yahoo.com

Aya Youssef Mohamed, Lecturer

CONTACT

01013244819Aya_badran@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

November 1, 2018

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

EG(1)