Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phototherapeutic | Experimental | 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 | Active Comparator | One monthly injections of intralesional potent corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hoda M Rasheed, MD | Cairo University | Study Chair |
| Nermin El-Eishi, MD | Cairo University | Principal Investigator |
| Vanessa G Hafez, MD | Cairo University | Principal Investigator |
| Solwan I Elsamanoudy, MBBCh | Cairo University | Principal Investigator |
| Rehab A Hegazy, MD | Cairo University | Principal Investigator |
| Olfat G Shaker, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department - faculty of medicine- Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30411986 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D014221 | Triamcinolone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Triamcinolone Acetonide | Drug | One monthly injections of intralesional triamcinolone acetonide |
|
| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |