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

This study is currently recruiting participants.
Verified August 2012 by Siriraj Hospital
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT00999869
First received: October 21, 2009
Last updated: August 6, 2012
Last verified: August 2012
  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:


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

  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
  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:

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:
Hypotrichosis
Alopecia
Alopecia Areata
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 April 20, 2014