The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
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|ClinicalTrials.gov Identifier: NCT00997815|
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : August 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Recalcitrant Alopecia Totalis Recalcitrant Alopecia Universalis||Drug: Botulinum toxin A Drug: Normal saline injection||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||June 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|