The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata

Summary

Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is still unclear, however, it is believed to be an autoimmune disease. This disease is not a life-threatening condition but it has a significant psychological impact to patient's quality of life.

Many triggers have been proposed such as viral infection, stress and neurologic factors. There are many studies show the correlation between disease activities and neurotransmitters level. Substance P and calcitonin gene-related peptide play major role in early stage of disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss of immune privilege of hair follicles.

The conventional treatment of alopecia areata with intralesional corticosteroid injection might treat the end of pathogenesis process.

There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates inhibition release of substance P in many publications.

To sum up, the treatment of alopecia areata with intralesional corticosteroid injection still be a standard treatment, nevertheless, patients have to receive this treatment every month until regrowth of scalp hair. Corticosteroid injection have several side effects, for example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression. Moreover, injection pain is also affect to psychological aspect .

This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and reduce corticosteroid side effects, as well as, others opportunity cost. There is no prospective, randomized-controlled trial of comparison study between botulinum toxin A injection and corticosteroid injection for alopecia areata, therefore, investigators conduct this study for the greatest benefit to alopecia areata patients and for the future research in disease etiology.

Conditions

• Alopecia Areata

Interventions

DRUG

Botulinum toxin type A

Using concentration at 2 units per 0.1 of dilution with normal saline Injection in the first visit and follow up at 1 week, 1,2,3 and 4 months after injection

DRUG

Triamcinolone acetonide

Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution

Sponsors & Collaborators

• Siriraj Hospital

  lead OTHER

Principal Investigators

• Rattapon Thoungtong, MD. · Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand

• Supenya Varothai, MD. · Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand

• Rasthawathana Desomchoke, MD. · Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand

• Kumpol Aiempanakit, M.D. · Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2012-12-31

Completion

2013-02-28

Countries

• Thailand

Study Locations