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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT00997815
First received: October 18, 2009
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  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 Phase
Recalcitrant Alopecia Totalis
Recalcitrant Alopecia Universalis
 Drug: Botulinum toxin A
Drug: Normal saline injection
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

MedlinePlus related topics: Botox
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 ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin A
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
Other Name: Botox
Placebo Comparator: Placebo
Using normal saline
 Drug: Normal saline injection
Using normal saline 2.5 ml injected in control side

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997815

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: Rattapon Thuangtong, Assistant professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00997815     History of Changes
Other Study ID Numbers: SirirajH
Study First Received: October 18, 2009
Last Updated: August 1, 2012
Health Authority: Thailand: Ethical comittee

Keywords provided by Siriraj Hospital:
Recalcitrant
Alopecia totalis
Alopecia universalis
Botulinum toxin A

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013