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

Primary Purpose

Recalcitrant Alopecia Totalis, Recalcitrant Alopecia Universalis

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Botulinum toxin A

Normal saline injection

About this trial

This is an interventional treatment trial for Recalcitrant Alopecia Totalis focused on measuring Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum toxin A

Placebo

Arm Description

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.

Using normal saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00997815

First Posted

October 18, 2009

Last Updated

August 1, 2012

Sponsor

Siriraj Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00997815

Brief Title

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Siriraj Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recalcitrant Alopecia Totalis, Recalcitrant Alopecia Universalis

Keywords

Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum toxin A

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Using normal saline

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A

Other Intervention Name(s)

Botox

Intervention Description

Concentration at 2 units per 0.1 of normal saline dilution

Intervention Type

Drug

Intervention Name(s)

Normal saline injection

Intervention Description

Using normal saline 2.5 ml injected in control side

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rattapon Thoungtong, MD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Supenya Varothai, MD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rasthawathana Desomchoke, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suthasinee Pattaravadee, B.Sc

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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