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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Siriraj Hospital.
Recruitment status was  Recruiting
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

October 21, 2009
August 6, 2012
November 2009
December 2012   (final data collection date for primary outcome measure)
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999869 on ClinicalTrials.gov Archive Site
Possible side effects of intralesional botulinum toxin a injection [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Alopecia Areata
  • 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.)
  • Drug: Triamcinolone acetonide
    Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution
    Other Name: Kenacort
  • 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 ).
    Intervention: Drug: Botulinum toxin type A
  • Active Comparator: Triamcinolone acetonide
    At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side
    Intervention: Drug: Triamcinolone acetonide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Thailand
 
NCT00999869
SirirajH-2
Yes
Rattapon Thuangtong, Siriraj Hospital
Siriraj Hospital
Not Provided
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
Siriraj Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP