The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis - Full Text View

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

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Botox Hair Problems

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:

To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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

Criteria

Inclusion Criteria:

All patients must be over 18 years old
All patients are diagnosed with alopecia totalis or alopecia universalis
The alopecia condition was not responded to any treatments

Exclusion Criteria:

Having an active inflammation on scalp area
Allergic to botulinum toxin A of human albumin
Has been diagnosed with neuromuscular disorders
Taking any medication that may interfere with botulinum toxin A action
Receiving any treatment for alopecia condition within 4 weeks
Pregnant , breastfeeding, plan to pregnant patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997815

Contacts

Contact: Rattapon Thuangtong, MD

(66)-2--419-7000 ext 4332

rattaponthuangtong@yahoo.com

Locations

Thailand
Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700

Sponsors and Collaborators

Siriraj Hospital

Investigators

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

No publications provided

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

Keywords provided by Siriraj Hospital:

Recalcitrant
Alopecia totalis
Alopecia universalis
Botulinum toxin A

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hair Diseases
Alopecia Areata
Hypotrichosis
Botulinum Toxins
Skin Diseases

Anti-Dyskinesia Agents
Therapeutic Uses
Alopecia
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010