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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997815

Enrollment

Registered

2009-10-19

Start date

2009-12-31

Completion date

2011-06-30

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recalcitrant Alopecia Totalis, Recalcitrant Alopecia Universalis

Keywords

Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A

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.

Interventions

DRUGBotulinum toxin A

Concentration at 2 units per 0.1 of normal saline dilution

DRUGNormal saline injection

Using normal saline 2.5 ml injected in control side

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection	4 months

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026