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

NCT00999869 | Unknown DMC

• 1 other identifier: SirirajH-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Newly diagnosed; Alopecia areata; Botulinum toxin A; Corticosteroid; Intralesional injection

Outcome Measures

Primary Outcomes (1)

• The percentage of terminal hair regrowth after intralesional botulinum toxin A injection

  4 months

Secondary Outcomes (1)

• Possible side effects of intralesional botulinum toxin a injection

  4 months

Study Arms (2)

Botulinum toxin A

EXPERIMENTAL

At first visit, patients will be randomized by blocked randomization into 2 sides of scalp. Experimental side will be injected with botulinum toxin A ( Botox) 2 units per 6.05 cm2 of lesion ( Concentration 2 units of Botox per 0.1 ml of normal saline ).

Drug: Botulinum toxin type A

Triamcinolone acetonide

ACTIVE COMPARATOR

At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side

Drug: Triamcinolone acetonide

Interventions

Botulinum toxin type A DRUG

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

Also known as: Botox( Allergan Inc.)

Botulinum toxin A

Triamcinolone acetonide DRUG

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

Also known as: Kenacort

Triamcinolone acetonide

Eligibility Criteria

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

You may qualify if:

• Patients must be above 18 years old
• Newly diagnosed with multiple alopecia areata
• Patient has lesions on the both side of the scalp.
• Lesions's diameter varies between 2-6 cms

You may not qualify if:

• Having active scalp inflammation
• Allergic to botulinum toxin A or human albumin
• Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
• Diagnosed with neuromuscular diseases such as Myasthenia gravis
• Pregnant, breast feeding, plan to pregnant patients

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (2)

Siriraj hospital

Bangkok, Bangkok, 10700, Thailand

RECRUITING

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

Bangkok, 10700, Thailand

NOT YET RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Alopecia Areata

Interventions

Botulinum Toxins, Type A; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Rattapon Thoungtong, MD.

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

  STUDY CHAIR

• Supenya Varothai, MD.

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

  STUDY DIRECTOR

• Rasthawathana Desomchoke, MD.

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

  PRINCIPAL INVESTIGATOR

• Kumpol Aiempanakit, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rattapon Thuangtong, MD.

CONTACT

(66)-2-419-7000; rattaponthuangtong@yahoo.com

Supenya Varothia, MD.

CONTACT

(66)-2-419-7000; supenya_v@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance professor

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

TH (2)