NCT01559584

A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial

Completed NA Last updated 5 April 2014

What this trial tests

NA trial testing ultraviolet A (UVA) in Alopecia Areata in 40 participants. Completed in 1 March 2014.

Timeline

1 March 2012

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 March 2012
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	1 location across Egypt

Drugs / interventions tested

• ultraviolet A (UVA)
• Triamcinolone Acetonide — full drug profile →

Conditions studied

• Alopecia Areata — all drugs for Alopecia Areata →

Sponsor

Cairo University

Who can join

12 and older, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Treatment success
  Time frame: After six months from onset of treatment
  Treatment success defined as effective sustained growth of hair in more than 80% of the affected area at the EOS. Clinical assessment will be performed by one non-blinded, and two blinded investigators.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A clinical and immunological study of phototoxic regimen of ultraviolet A for treatment of alopecia areata: a randomized controlled clinical trial.
   El-Mofty M, Rasheed H, El-Eishy N, Hegazy RA, et al · · 2019 · cited 9× · PMID 30411986 · DOI 10.1080/09546634.2018.1543847