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

NCT00997815 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-08-02

No results posted yet for this study

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.

Conditions

  • Recalcitrant Alopecia Totalis
  • Recalcitrant Alopecia Universalis

Interventions

DRUG

Botulinum toxin A

Concentration at 2 units per 0.1 of normal saline dilution

DRUG

Normal saline injection

Using normal saline 2.5 ml injected in control side

Sponsors & Collaborators

  • Siriraj Hospital

    lead OTHER

Principal Investigators

  • Rattapon Thoungtong, MD · Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University

  • Supenya Varothai, MD · Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

  • Rasthawathana Desomchoke, MD · Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

  • Suthasinee Pattaravadee, B.Sc · Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997815 on ClinicalTrials.gov