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Completed

NCT Number: NCT00997815

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

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.

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Key information

Conditions

Recalcitrant Alopecia Totalis Alopecia universalis Recalcitrant Alopecia Universalis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

Concentration at 2 units per 0.1 of normal saline dilution

Other names: Botox

Normal saline injection

Drug

Using normal saline 2.5 ml injected in control side

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 19, 2009
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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