The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.
Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.
The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.
There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.
Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.
The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.
|Recalcitrant Alopecia Totalis Recalcitrant Alopecia Universalis||Drug: Botulinum toxin A Drug: Normal saline injection||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis|
- To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection [ Time Frame: 4 months ]
- To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis [ Time Frame: 4 months ]
|Study Start Date:||December 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Botulinum toxin A
The area of alopecia is splited into experimental and control sides by blocked randomization. Experimental sides injected with botulinum toxin A at 2 units per 0.1 ml of dilution with normal saline entire all area.
Drug: Botulinum toxin A
Concentration at 2 units per 0.1 of normal saline dilution
Other Name: Botox
Placebo Comparator: Placebo
Using normal saline
Drug: Normal saline injection
Using normal saline 2.5 ml injected in control side
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997815
|Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Study Chair:||Rattapon Thoungtong, MD||Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University|
|Study Director:||Supenya Varothai, MD||Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Principal Investigator:||Rasthawathana Desomchoke, MD||Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Principal Investigator:||Suthasinee Pattaravadee, B.Sc||Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University|