Dermox

Como agente de repigmentación tópico en vitiligo junto con dosis controladas de ultravioleta A (320-400 nm) o luz solar.

Administración

Dermox Lotion se aplica a un área de vitiligo bien definida por el médico y el área se expone a un crédito adecuado de UVA. El tiempo de exposición inicial debe ser conservador y no debe exceder lo que se predice que es la mitad de la dosis mínima de eritema. Los intervalos de tratamiento deben estar regulados por la respuesta al eritema; generalmente se recomienda una vez a la semana o con menos frecuencia dependiendo de los resultados. Las manos y los dedos de la persona que aplica el medicamento deben estar protegidos con guantes o cunas para evitar la fotosensibilización y posibles quemaduras.

La pigmentación puede comenzar después de unas pocas semanas, pero la repigmentación significativa puede requerir de 6 a 9 meses de tratamiento. El nuevo tratamiento periódico puede ser necesario para retener todo el nuevo pigmento. El vitiligo idiopático es reversible pero no igualmente reversible en cada paciente. El tratamiento debe ser individualizado. La repigmentación variará en integridad, tiempo de inicio y duración. La repigmentación ocurre más rápidamente en áreas de carne como la cara, el abdomen y las nalgas y menos rápidamente en áreas menos carnes, como el dorso de las manos o los pies.

1. Patients exhibiting idiosyncratic reactions to psoralen compounds or a history of sensitivity reactions to them.
2. Patients exhibiting melanoma or with a history of melanoma.
3. Patients exhibiting invasive skin carcinoma generally.
4. Patients with photosensitivity diseases such as porphyria, acute lupus erythematosus, xeroderma pigmentosum, etc.
5. Children under 12 since clinical studies to determine the efficacy and safety of treatment in this age group have not been done.

WARNINGS

Skin Burns

Serious skin burns from either UVA or sunlight (even through window glass) can result if recommended exposure schedule is exceeded and/or protective covering or sunscreens are not used. The blistering of the skin sometimes encountered after UV exposure generally heals without complication or scarring. (Farrington Daniels, Jr., M.D., personal communication). Suitable covering of the area of application or a topical sunblock should follow the therapeutic UVA exposure.

Carcinogenicity

Animal Studies

Topical methoxsalen has been reported to be a potent photocarcinogen in certain strains of mice. (Pathak et al 1959)⁵.

Human Studies

None of our clinical investigators reported skin cancer as a complication of topical treatment for vitiligo. However, it is recommended that caution be exercised when the patient is fair-skinned, has a history of prior coal tar UV treatment, or has had ionizing radiation or taken arsenical compounds. Such patients who subsequently have oral psoralen – UVA treatment (PUVA) are at increased risk for developing skin cancer.

Concomitant Therapy

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.

REFERENCES

5. Pathak, M.A.; Daniels, F.; Hopkins, C.E.; Fitzpatrick, T.B.: Ultraviolet carcinogenesis in albino and pigmented mice receiving furocoumarins: psoralens and 8-methoxypsoralen, Nature, 183, pp. 728-730 (1959).

PRECAUTIONS

This product should be applied only in small well-defined lesions and preferably on lesions which can be protected by clothing or a sunscreen from subsequent exposure to radiant UVA. If this product is used to treat vitiligo of face or hands, be very emphatic when instructing patient to keep the treated areas protected from light by use of protective clothing or sunscreening agents. The area of application may be highly photosensitive for several days and may result in severe burn injury if exposed to additional UV or sunlight.

Carcinogenesis

See WARNING Section.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical methoxsalen. It is also not known whether methoxsalen can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical methoxsalen is absorbed systemically. Topical methoxsalen should be used in women only when clearly indicated.

Nursing Mothers

It is not known whether topical methoxsalen is absorbed or excreted in human milk. Caution is advised when topical methoxsalen is used in a nursing mother.

Pediatric Usage

Safety and effectiveness in children below the age of 12 years have not been established.

Systemic adverse reactions have not been reported. The most common adverse reaction is severe burns of the treated area from overexposure to UVA, including sunlight. TREATMENT MUST BE INDIVIDUALIZED. Minor blistering of the skin is not a contraindication to further treatment and generally heals without incident. Treatment would be the standard for burn therapy. Since 1953, many studies have demonstrated the safety and effectiveness of topical methoxsalen and UVA for the treatment of vitiligo when used as directed. (Lerner, A.B., et al, 1953)⁶ (Fitzpatrick, T.B., et al, 1966)⁷ (Fulton, James F. et al, 1969)⁸

Esto no se aplica al uso tópico. En el improbable caso de que se ingiera la loción, se deben seguir los procedimientos estándar para la intoxicación, incluido el lavado gástrico. También sería necesaria la protección contra los rayos UVA o la luz del día durante horas o días. El paciente debe mantenerse en una habitación oscura.