The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
Recruitment status was: Recruiting
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 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|
- The percentage of terminal hair regrowth after intralesional botulinum toxin A injection [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Possible side effects of intralesional botulinum toxin a injection [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|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)|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999869
|Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Bangkok, Thailand, 10700|
|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|