Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata

Study Overview
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Brief Summary
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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.

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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Radiation: ultraviolet A (UVA)
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phototherapeutic<br>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. | Radiation: ultraviolet A (UVA)<br>* 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.<br>|
| Active Comparator: Conventional therapy<br>One monthly injections of intralesional potent corticosteroids | Drug: Triamcinolone Acetonide<br>* One monthly injections of intralesional triamcinolone acetonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | 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. | After six months from onset of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue cytokines response to therapy | 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 | At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation. | After six months from onset of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia, Areata, Phototherapy, Phototoxic, Ultraviolet A, Randomized controlled trial, Interferon gamma, Transforming growth factor beta-1, Insulin like growth factor-1