The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
NCT ID: NCT00997815
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2009-12-31
2011-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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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.
Botulinum toxin A
Concentration at 2 units per 0.1 of normal saline dilution
Placebo
Using normal saline
Normal saline injection
Using normal saline 2.5 ml injected in control side
Interventions
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Botulinum toxin A
Concentration at 2 units per 0.1 of normal saline dilution
Normal saline injection
Using normal saline 2.5 ml injected in control side
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. All patients are diagnosed with alopecia totalis or alopecia universalis
3. The alopecia condition was not responded to any treatments
Exclusion Criteria
2. Allergic to botulinum toxin A of human albumin
3. Has been diagnosed with neuromuscular disorders
4. Taking any medication that may interfere with botulinum toxin A action
5. Receiving any treatment for alopecia condition within 4 weeks
6. Pregnant , breastfeeding, plan to pregnant patients
18 Years
ALL
No
Sponsors
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Siriraj Hospital
OTHER
Responsible Party
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Rattapon Thuangtong
Assistant professor
Principal Investigators
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Rattapon Thoungtong, MD
Role: STUDY_CHAIR
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University
Supenya Varothai, MD
Role: STUDY_DIRECTOR
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Rasthawathana Desomchoke, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Suthasinee Pattaravadee, B.Sc
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Locations
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Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, , Thailand
Countries
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Other Identifiers
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SirirajH
Identifier Type: -
Identifier Source: org_study_id