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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

Page last updated: August 23, 2015

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