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

August 1, 2012 updated by: Rattapon Thuangtong, Siriraj Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Botox
PLACEBO_COMPARATOR: Placebo
Using normal saline
Drug: Normal saline injection
Using normal saline 2.5 ml injected in control side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (ESTIMATE)

October 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SirirajH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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