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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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
    


Study Type

Interventional


Primary Outcome

The percentage of terminal hair regrowth after intralesional botulinum toxin A injection

Secondary Outcome

 Possible side effects of intralesional botulinum toxin a injection

Condition

Alopecia Areata

Intervention

Botulinum toxin type A

Study Arms / Comparison Groups

 Botulinum toxin A
Description:  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 ).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

November 2009

Completion Date

February 2013

Primary Completion Date

December 2012

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rattapon Thoungtong, MD., (66)-2-419-7000, [email protected]

Location Countries

Thailand

Location Countries

Thailand

Administrative Informations


NCT ID

NCT00999869

Organization ID

SirirajH-2


Responsible Party

Principal Investigator

Study Sponsor

Siriraj Hospital


Study Sponsor

Rattapon Thoungtong, MD., Study Chair, Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand


Verification Date

August 2012