The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00999869
• Other study ID #: SirirajH-2
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2009
• Last updated: August 6, 2012
• Start date: November 2009
• Est. completion date: February 2013

Study information

• Verified date: August 2012
• Source: Siriraj Hospital
• Contact: Rattapon Thuangtong, MD.
• Phone: (66)-2-419-7000
• Email: rattaponthuangtong[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Inclusion criteria

1. Patients must be above 18 years old

2. Newly diagnosed with multiple alopecia areata

3. Patient has lesions on the both side of the scalp.

4. Lesions's diameter varies between 2-6 cms

Exclusion criteria

1. Having active scalp inflammation

2. Allergic to botulinum toxin A or human albumin

3. Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications

4. Diagnosed with neuromuscular diseases such as Myasthenia gravis

5. Pregnant, breast feeding, plan to pregnant patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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
• Triamcinolone acetonide
Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University	Bangkok
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004413. doi: 10.1002/14651858.CD004413.pub2. Review. — View Citation

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. — View Citation

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. doi: 10.1159/000111523. Epub 2008 Jan 23. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

Paus R, Heinzelmann T, Schultz KD, Furkert J, Fechner K, Czarnetzki BM. Hair growth induction by substance P. Lab Invest. 1994 Jul;71(1):134-40. — View Citation

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. doi: 10.1016/j.jaad.2007.10.645. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of terminal hair regrowth after intralesional botulinum toxin A injection		4 months	No
Secondary	Possible side effects of intralesional botulinum toxin a injection		4 months	Yes