Clinical trial NCT00997815: The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
Official title: The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Recalcitrant Alopecia Totalis
Recalcitrant Alopecia Universalis
Keywords: Recalcitrant
Alopecia totalis
Alopecia universalis
Botulinum toxin A
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
timeFrame: 4 months
Secondary outcomes:
measure: To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University
name: Rattapon Thoungtong, MD
role: STUDY_CHAIR
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Supenya Varothai, MD
role: STUDY_DIRECTOR
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Rasthawathana Desomchoke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Suthasinee Pattaravadee, B.Sc
role: PRINCIPAL_INVESTIGATOR
References: