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

August 6, 2012 updated by: Rattapon Thuangtong, Siriraj Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Suthasinee Pattaravadee, B.Sc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Kenacort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Possible side effects of intralesional botulinum toxin a injection
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SirirajH-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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