The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata - Full Text View

Purpose

Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is still unclear, however, it is believed to be an autoimmune disease. This disease is not a life-threatening condition but it has a significant psychological impact to patient's quality of life.

Many triggers have been proposed such as viral infection, stress and neurologic factors. There are many studies show the correlation between disease activities and neurotransmitters level. Substance P and calcitonin gene-related peptide play major role in early stage of disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss of immune privilege of hair follicles.

The conventional treatment of alopecia areata with intralesional corticosteroid injection might treat the end of pathogenesis process.

There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates inhibition release of substance P in many publications.

To sum up, the treatment of alopecia areata with intralesional corticosteroid injection still be a standard treatment, nevertheless, patients have to receive this treatment every month until regrowth of scalp hair. Corticosteroid injection have several side effects, for example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression. Moreover, injection pain is also affect to psychological aspect .

This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and reduce corticosteroid side effects, as well as, others opportunity cost. There is no prospective, randomized-controlled trial of comparison study between botulinum toxin A injection and corticosteroid injection for alopecia areata, therefore, investigators conduct this study for the greatest benefit to alopecia areata patients and for the future research in disease etiology.

Condition	Intervention
Alopecia Areata	Drug: Botulinum toxin type A Drug: Triamcinolone acetonide

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata

Resource links provided by NLM:

MedlinePlus related topics: Botox Steroids

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:

The percentage of terminal hair regrowth after intralesional botulinum toxin A injection [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Possible side effects of intralesional botulinum toxin a injection [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2009
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Botulinum toxin A At first visit, patients will be randomized by blocked randomization into 2 sides of scalp. Experimental side will be injected with botulinum toxin A ( Botox) 2 units per 6.05 cm2 of lesion ( Concentration 2 units of Botox per 0.1 ml of normal saline ).	Drug: Botulinum toxin type A Using concentration at 2 units per 0.1 of dilution with normal saline Injection in the first visit and follow up at 1 week, 1,2,3 and 4 months after injection Other Name: Botox( Allergan Inc.)
Active Comparator: Triamcinolone acetonide At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side	Drug: Triamcinolone acetonide Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution Other Name: Kenacort

Detailed Description:

Inclusion criteria

Patients must be above 18 years old
Newly diagnosed with multiple alopecia areata
Patient has lesions on the both side of the scalp.
Lesions's diameter varies between 2-6 cms

Exclusion criteria

Having active scalp inflammation
Allergic to botulinum toxin A or human albumin
Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
Diagnosed with neuromuscular diseases such as Myasthenia gravis
Pregnant, breast feeding, plan to pregnant patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Patients must be above 18 years old
Newly diagnosed with multiple alopecia areata
Patient has lesions on the both side of the scalp.
Lesions's diameter varies between 2-6 cms

Exclusion criteria

Having active scalp inflammation
Allergic to botulinum toxin A or human albumin
Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
Diagnosed with neuromuscular diseases such as Myasthenia gravis
Pregnant, breast feeding, plan to pregnant patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999869

Contacts

Contact: Rattapon Thuangtong, MD.	(66)-2-419-7000 ext 4332	rattaponthuangtong@yahoo.com
Contact: Supenya Varothia, MD.	(66)-2-419-7000 ext 4332	supenya_v@yahoo.com

Locations

Thailand
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University	Not yet recruiting
Bangkok, Thailand, 10700
Contact: Rattapon Thuangtong, MD. (66)-2-419-7000 ext 4332 rattaponthuangtong@yahoo.com
Contact: Supenya Varathai, MD. (66)-2-419-7000 ext 4332 supenya_v@yahoo.com
Sub-Investigator: Suthasinee Pattaravadee, B.Sc
Siriraj hospital	Recruiting
Bangkok, Thailand, 10700
Contact: Rattapon Thuangtong, M.D. rattaponthuangtong@yahoo.com

Sponsors and Collaborators

Siriraj Hospital

Investigators

Study Chair:	Rattapon Thoungtong, MD.	Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Study Director:	Supenya Varothai, MD.	Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Principal Investigator:	Rasthawathana Desomchoke, MD.	Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Principal Investigator:	Kumpol Aiempanakit, M.D.	Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand

More Information

Publications:

Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33.

McDonagh AJ, Messenger AG. The pathogenesis of alopecia areata. Dermatol Clin. 1996 Oct;14(4):661-70. Review.

Jackow C, Puffer N, Hordinsky M, Nelson J, Tarrand J, Duvic M. Alopecia areata and cytomegalovirus infection in twins: genes versus environment? J Am Acad Dermatol. 1998 Mar;38(3):418-25.

Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004413. Review.

Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7.

Kar BR, Handa S, Dogra S, Kumar B. Placebo-controlled oral pulse prednisolone therapy in alopecia areata. J Am Acad Dermatol. 2005 Feb;52(2):287-90.

Lassus A, Eskelinen A, Johansson E. Treatment of alopecia areata with three different PUVA modalities. Photodermatol. 1984 Jun;1(3):141-4.

Mitchell AJ, Douglass MC. Topical photochemotherapy for alopecia areata. J Am Acad Dermatol. 1985 Apr;12(4):644-9.

Tosti A, De Padova MP, Minghetti G, Veronesi S. Therapies versus placebo in the treatment of patchy alopecia areata. J Am Acad Dermatol. 1986 Aug;15(2 Pt 1):209-10.

Vestey JP, Savin JA. A trial of 1% minoxidil used topically for severe alopecia areata. Acta Derm Venereol. 1986;66(2):179-80.

Fransway AF, Muller SA. 3 percent topical minoxidil compared with placebo for the treatment of chronic severe alopecia areata. Cutis. 1988 Jun;41(6):431-5. Review.

Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. PubMed PMID: 3549809.

Fiedler-Weiss VC, Buys CM. Evaluation of anthralin in the treatment of alopecia areata. Arch Dermatol. 1987 Nov;123(11):1491-3.

van der Steen PH, van Baar HM, Happle R, Boezeman JB, Perret CM. Prognostic factors in the treatment of alopecia areata with diphenylcyclopropenone. J Am Acad Dermatol. 1991 Feb;24(2 Pt 1):227-30.

Gupta AK, Ellis CN, Cooper KD, Nickoloff BJ, Ho VC, Chan LS, Hamilton TA, Tellner DC, Griffiths CE, Voorhees JJ. Oral cyclosporine for the treatment of alopecia areata. A clinical and immunohistochemical analysis. J Am Acad Dermatol. 1990 Feb;22(2 Pt 1):242-50.

Shapiro J, Lui H, Tron V, Ho V. Systemic cyclosporine and low-dose prednisone in the treatment of chronic severe alopecia areata: a clinical and immunopathologic evaluation. J Am Acad Dermatol. 1997 Jan;36(1):114-7.

Bui K, Polisetty S, Gilchrist H, Jackson SM, Frederic J. Successful treatment of alopecia universalis with alefacept: a case report and review of the literature. Cutis. 2008 May;81(5):431-4. Review.

Ettefagh L, Nedorost S, Mirmirani P. Alopecia areata in a patient using infliximab: new insights into the role of tumor necrosis factor on human hair follicles. Arch Dermatol. 2004 Aug;140(8):1012.

Strober BE, Siu K, Alexis AF, Kim G, Washenik K, Sinha A, Shupack JL. Etanercept does not effectively treat moderate to severe alopecia areata: an open-label study. J Am Acad Dermatol. 2005 Jun;52(6):1082-4.

Price VH, Hordinsky MK, Olsen EA, Roberts JL, Siegfried EC, Rafal ES, Korman NJ, Altrabulsi B, Leung HM, Garovoy MR, Caro I, Whiting DA. Subcutaneous efalizumab is not effective in the treatment of alopecia areata. J Am Acad Dermatol. 2008 Mar;58(3):395-402.

Fabre C, Dereure O. Worsening alopecia areata and de novo occurrence of multiple halo nevi in a patient receiving infliximab. Dermatology. 2008;216(2):185-6. Epub 2008 Jan 23.

Cutrer FM, Pittelkow MR. Cephalalgic alopecia areata: a syndrome of neuralgiform head pain and hair loss responsive to botulinum A toxin injection. Cephalalgia. 2006 Jun;26(6):747-51.

Olsen E, Hordinsky M, McDonald-Hull S, Price V, Roberts J, Shapiro J, Stenn K. Alopecia areata investigational assessment guidelines. National Alopecia Areata Foundation. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):242-6.

Hsu TS, Dover JS, Arndt KA. Effect of volume and concentration on the diffusion of botulinum exotoxin A. Arch Dermatol. 2004 Nov;140(11):1351-4.

Responsible Party:	Rattapon Thuangtong, Assistance professor, Siriraj Hospital
ClinicalTrials.gov Identifier:	NCT00999869 History of Changes
Other Study ID Numbers:	SirirajH-2
Study First Received:	October 21, 2009
Last Updated:	August 6, 2012
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Siriraj Hospital:

Newly diagnosed
Alopecia areata
Botulinum toxin A
Corticosteroid
Intralesional injection

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Botulinum Toxins
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Neuromuscular Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013