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

NCT00997815 | Completed Phase 2

• 1 other identifier: SirirajH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Recalcitrant; Alopecia totalis; Alopecia universalis; Botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection

  4 months

Secondary Outcomes (1)

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

  4 months

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

Using normal saline

Drug: Normal saline injection

Interventions

Botulinum toxin A DRUG

Concentration at 2 units per 0.1 of normal saline dilution

Also known as: Botox

Botulinum toxin A

Normal saline injection DRUG

Using normal saline 2.5 ml injected in control side

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

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

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Alopecia universalis

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rattapon Thoungtong, MD

  Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University

  STUDY CHAIR

• Supenya Varothai, MD

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 19, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

TH (1)