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| Sponsor: | Siriraj Hospital |
|---|---|
| Information provided by: | Siriraj Hospital |
| ClinicalTrials.gov Identifier: | NCT00997815 |
Purpose
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 | Intervention |
|---|---|
|
Recalcitrant Alopecia Totalis Recalcitrant Alopecia Universalis |
Drug: Botulinum toxin A |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Botulinum toxin A: Experimental
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rattapon Thuangtong, MD | (66)-2--419-7000 ext 4332 | rattaponthuangtong@yahoo.com |
| Thailand | |
| 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 |
More Information
| Responsible Party: | Faculty of Medicine Siriraj Hospital, Mahidol University ( Siriraj institutional review board ) |
| Study ID Numbers: | SirirajH |
| Study First Received: | October 18, 2009 |
| Last Updated: | December 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00997815 History of Changes |
| Health Authority: | Thailand:Siriraj Institutional Review Board |
|
Recalcitrant Alopecia totalis Alopecia universalis Botulinum toxin A |
|
Pathological Conditions, Anatomical Hair Diseases Alopecia Areata Hypotrichosis Botulinum Toxins Skin Diseases |
Anti-Dyskinesia Agents Therapeutic Uses Alopecia Central Nervous System Agents Pharmacologic Actions |