Recalcitrant Alopecia Totalis Clinical Trial
Official title:
The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
| Verified date | August 2012 |
| Source | Siriraj Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical comittee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2011 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. All patients must be over 18 years old 2. All patients are diagnosed with alopecia totalis or alopecia universalis 3. The alopecia condition was not responded to any treatments Exclusion Criteria: 1. Having an active inflammation on scalp area 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Siriraj Hospital |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection | 4 months | Yes | |
| Secondary | To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis | 4 months | Yes |