Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alopecia Areata |
Radiation: ultraviolet A (UVA) Drug: Triamcinolone Acetonide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial |
- Treatment success [ Time Frame: After six months from onset of treatment ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: After six months from onset of treatment ] [ Designated as safety issue: Yes ]Adverse events will be meticulously monitored all through the study, including hypo/hyper pigmentation, severe erythema, itching or burning sensation.
| Estimated Enrollment: | 44 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phototherapeutic
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)
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. |
|
Active Comparator: Conventional therapy
One monthly injections of intralesional potent corticosteroids
|
Drug: Triamcinolone Acetonide
One monthly injections of intralesional triamcinolone acetonide
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Vanessa G Hafez, MD | 01001688434 ext 002 | vanessahafez@hotmail.com |
| Egypt | |
| Dermatology department - faculty of medicine- Cairo University | Not yet recruiting |
| Cairo, Egypt | |
| Contact: Hoda M Rasheed, MD ho_rash@yahoo.com | |
| Contact vanessahafez@hotmail.com | |
| Principal Investigator: Hoda M Rasheed, MD | |
| Principal Investigator: Nermin El-Eishi, MD | |
| Principal Investigator: Vanessa G Hafez, MD | |
| Principal Investigator: Rehab A Hegazy, MD | |
| Principal Investigator: Solwan I Elsamanoudy, MD | |
| Principal Investigator: Olfat G Shaker, MD | |
| Study Chair: | Hoda M Rasheed, MD | Cairo University |
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Hoda Mohamed Rasheed, Professor, Cairo University |
| ClinicalTrials.gov Identifier: | NCT01559584 History of Changes |
| Other Study ID Numbers: | Phototoxic UVA in alopecia |
| Study First Received: | March 12, 2012 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Egypt: Institutional Review Board |
Keywords provided by Cairo University:
|
Alopecia Areata Phototherapy Phototoxic Ultraviolet A |
Randomized controlled trial Interferon gamma Transforming growth factor beta-1 Insulin like growth factor-1 |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Methoxsalen Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Photosensitizing Agents Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013