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NCT Number: NCT01559584

Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

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.

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Key information

Conditions

Alopecia Areata Alopecia Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hair Diseases Hypotrichosis Musculoskeletal Diseases Osteochondrodysplasias Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultraviolet A (UVA)

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.

Triamcinolone Acetonide

Drug

One monthly injections of intralesional triamcinolone acetonide

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tissue cytokines response to therapy

    Time frame: At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth

    Explanation at the molecular level of possible mechanisms underlying hair regrowth in responsive patients by assessing tissue levels of IFN-γ, IGF-1 and TGF-Beta1

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: After six months from onset of treatment

    Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2012
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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