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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Using normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Drug | Concentration at 2 units per 0.1 of normal saline dilution |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rattapon Thoungtong, MD | Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University | Study Chair |
| Supenya Varothai, MD | Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
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| Normal saline injection | Drug | Using normal saline 2.5 ml injected in control side |
|
| ID | Term |
|---|---|
| C537055 | Alopecia universalis |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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