Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

NCT ID: NCT01559584

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief Summary

Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a strong component of autoimmune origin. It is characterized by non-scarring hair loss on the scalp or any hair-bearing surface.

Various therapeutic agents have been described for the treatment of AA, but none are curative or preventive. The aim of AA treatment is to suppress the activity of the disease. Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well documented therapy for AA since 1978.

A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two previous studies. Sessions were carried out once every 3 months, and a higher efficacy with more encouraging response rates in comparison to the conventional PUVA therapy has been documented. This assumed upper hand over the conventional PUVA might be due to increasing the amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it has been suggested that it might play a role as a powerful initiating agent of suppression through direct action at the DNA level. However, still the exact effect of this treatment has not been fully clarified.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phototherapeutic

0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).

UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.

Group Type: EXPERIMENTAL

ultraviolet A (UVA)

Intervention Type: RADIATION

0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).

UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.

Conventional therapy

One monthly injections of intralesional potent corticosteroids

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

One monthly injections of intralesional triamcinolone acetonide

Interventions

ultraviolet A (UVA)

0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).

UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.

Intervention Type: RADIATION

Triamcinolone Acetonide

One monthly injections of intralesional triamcinolone acetonide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients presenting with alopecia areata, patchy type (max 3 patches not exceeding 50% of the scalp surface area) of more than 2 months duration.
• Age: 12 years and above

Exclusion Criteria

• Age: Less than 12 years old.
• Affection of more than 50% of the scalp area
• Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis,..
• Any present / past history of dermatological disease with a potential for koebnerization such as psoriasis, vitiligo.
• Diagnosis or history of any contraindication to receiving phototherapy such as malignancy, systemic lupus
• Dermoscopic evaluation revealing absence of any signs of presence of hair follicles.
• Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient.
• Patients with AA totalis or Ophiasis

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hoda Mohamed Rasheed

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hoda M Rasheed, MD

Role: STUDY_CHAIR

Cairo University

Nermin El-Eishi, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Vanessa G Hafez, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Solwan I Elsamanoudy, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Rehab A Hegazy, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Olfat G Shaker, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Dermatology department - faculty of medicine- Cairo University

Cairo, , Egypt

Countries

Egypt

References

El-Mofty M, Rasheed H, El-Eishy N, Hegazy RA, Hafez V, Shaker O, El-Samanoudy SI. A clinical and immunological study of phototoxic regimen of ultraviolet A for treatment of alopecia areata: a randomized controlled clinical trial. J Dermatolog Treat. 2019 Sep;30(6):582-587. doi: 10.1080/09546634.2018.1543847. Epub 2019 Jan 8.

Reference Type: DERIVED

PMID: 30411986 (View on PubMed)

Other Identifiers

Phototoxic UVA in alopecia

Identifier Type: -

Identifier Source: org_study_id