Clinical trial NCT01559584: Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata
Official title: A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia
Areata
Phototherapy
Phototoxic
Ultraviolet A
Randomized controlled trial
Interferon gamma
Transforming growth factor beta-1
Insulin like growth factor-1
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment success
timeFrame: After six months from onset of treatment
Secondary outcomes:
measure: Tissue cytokines response to therapy
timeFrame: At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: After six months from onset of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology department - faculty of medicine- Cairo University
Study officials:
affiliation: Cairo University
name: Hoda M Rasheed, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Nermin El-Eishi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Vanessa G Hafez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Solwan I Elsamanoudy, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Rehab A Hegazy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Olfat G Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.