Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Ameluz for Actinic Keratosis

Biofrontera news release; 2016 May 11

The FDA has approved Ameluz (aminolevulinic acid hydrochloride; Biofrontera) gel, for the treatment of mild-to-moderate actinic keratosis (AK) on the face and scalp.

Indications: Ameluz gel is a porphyrin precursor, which is used in combination with photodynamic therapy using the BF-RhodoLED lamp. It is indicated for lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp.

Dosage/administration: Each gram of Ameluz gel 10% contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid). Ameluz gel is to be administered by a health care provider and is for topical use only. Photodynamic therapy with Ameluz involves preparation of lesions, application of the product, and occlusion and illumination with BF-RhodoLED. Lesions that have not completely resolved 3 months after the initial treatment should be retreated.

Adverse reactions: The most common adverse reactions (≥10%) were application site erythema, pain/burning, irritation, edema, pruritis, exfoliation, scab, induration, and vesicles.

Citation: Biofrontera announces US FDA approval of Ameluz and activating BF-RhodoLED device for treatment of actinic keratosis. [news release]. Leverkusen, Germany: Biofrontera; May 11, 2016: Accessed May 11, 2016.

This Week's Must Reads

Sexual Minority Men and Tanning Behavior Examined, JAMA Dermatology; ePub 2018 Feb 28; Gao, et al

Patients with HS Have Higher Substance Abuse Odds, J Am Acad Dermatol; ePub 2018 Feb 27; Garg, et al

Patient QOL Fluctuates Before & After Mohs Surgery, J Am Acad Dermatol; ePub 2018 Mar 5; Zhang, et al

Sex-Specific Prognostic Implications in Melanoma, J Am Acad Dermatol; ePub 2018 Mar 5; Sinnamon, et al

Trends in Atopic Dermatitis Management, J Drugs Dermatol; 2018 Feb; He, Feldman, et al

Must Reads in Actinic Keratosis

Red Light ALA PDT Well Tolerated in AK Treatment, Photomed Laser Surg; ePub 2017 Dec 11; Paragh, et al

Cost of Managing AK Varies by Region, JAMA Dermatol; ePub 2017 Mar 1; Kirby, et al

Physician Wording Role in Seeking AK Treatment, JAMA Dermatol; ePub 2017 Jan 18; Berry, Butt, et al

Acantholysis in SCC Not Considered High Risk, J Am Acad Dermatol; ePub 2016 Nov 23; Ogawa, et al

Prevalence of Nonmelanoma Skin Cancers High in VHA, Dermatol Surg; ePub 2016 Jul 25; Yoon, Phibbs, et al