The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
Information source: Siriraj Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recalcitrant Alopecia Totalis; Recalcitrant Alopecia Universalis
Intervention: Botulinum toxin A (Drug); Normal saline injection (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Siriraj Hospital Official(s) and/or principal investigator(s): Rattapon Thoungtong, MD, Study Chair, Affiliation: Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University Supenya Varothai, MD, Study Director, Affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Rasthawathana Desomchoke, MD, Principal Investigator, Affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Suthasinee Pattaravadee, B.Sc, Principal Investigator, Affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Summary
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.
Clinical Details
Official title: The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
Secondary outcome: To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information
Starting date: December 2009
Last updated: August 1, 2012
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