Condition: Medicated for patients suffering from dermatology diseases.
Ease of Use: ★★★★
Dermatological diseases have become a serious threat now-a-days among the people. It has become a communicable disease in spite of taking in the various precautions and medicines. FDA has now approved a dermatology related drug named as Ameluz (aminolevulinic acid hydrochloride) which can be helpful to a greater extent.
Ameluz is a porphyrin precursor which is exclusively a combination of PDT i.e. Photodynamic therapy using BF-RhodoLED lamp, a narrow band, red light illumination source for scratch-directed and field directed treatment for actinic keratoses (AKs) of mild to moderate harshness on the scalp and the face.
It is used as a gel for topical medication. A single or an entire wound can be treated in combination with red light Photodynamic therapy (PDT) which in turn requires supervision of Ameluz and BF-RhodoLED light.
FDA Approval:
Three randomized, multicenter trials (Trials 1, 2, and 3) using a narrow spectrum lamp i.e. red light lamp were the base of approval by the FDA. Trail 2 and 3 were vehicle controlled and even double blind. Whereas Trail 1 was double-blind with regards to vehicle and observer blind concerning the active comparator arm. The clinical trial had regular reviews after 6 to 12 months. During the trails, out of 212 samples who had 4 to 8 wounds on the face, forehead, and on bald head were nursed with Ameluz and a narrow band spectrum lamp.
In all the trails, the wounds were not cured completely till 12 weeks of the initial treatment, and the healing was done even for the second time. The principal endpoint for all trials was total clearance 12 weeks after the last PDT.
It should be protected from sun light exposure for 48 hours. As a precautionary measure, it should not be consumed during pregnancy.
Side-effects: Erythema, burning, scab, induration, exfoliation, vesicle, to name a few.
