FDA approved Ameluz (aminolevulinic acid) for Actinic Keratoses of the Face and ScalpFDA approved New Gel and Light Treatment for Sun Damage on Face and Scalp

FDA From the archive Source published May 10, 2016 Summary added September 11, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Ameluz with red light PDT for mild-to-moderate facial/scalp AKs; apply by provider, max 60 cm2.

The FDA has approved Ameluz for the treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. The approval specifies use in combination with photodynamic therapy (PDT) using the BF-RhodoLED or RhodoLED XL lamp, a narrowband red light illumination source. The indication covers both lesion-directed and field-directed treatment.

Ameluz is a topical porphyrin precursor that must be administered by a health care provider. PDT with Ameluz involves lesion preparation, application of the gel, occlusion for 3 hours, and illumination with red light at approximately 635 nm and a dose of about 37 J/cm2. The product is applied as a 1 mm thick layer, with a maximum application area of 60 cm2 and a maximum of 6 grams per treatment session. Retreat lesions that have not completely resolved after 3 months.

This approval provides clinicians with an additional option for field-directed therapy of AKs, a common premalignant condition. The label does not include clinical trial efficacy data.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ameluz is a porphyrin precursor. When applied topically and illuminated with red light, it is intended to produce a photodynamic effect. The exact mechanism is not further described in the label.

Indication & Patient Population

Ameluz, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.

Dosing & Administration

Administer only by a health care provider. For topical use only. Not for ophthalmic, oral, or intravaginal use.

Apply an approximately 1 mm thick layer to skin lesion(s). Cover individual lesions or the entire AK-field, including approximately 5 mm of surrounding skin. Do not exceed an application area of 60 cm2. Do not use more than 6 grams (3 tubes) at one time.

PDT is a multi-stage process: 1. Preparation: Wipe lesions with ethanol or isopropanol-soaked cotton pad to degrease. Remove scaling and crusts, gently roughen lesion surfaces, avoiding bleeding. 2. Application: Apply gel using glove-protected fingertips or spatula. For lesion-directed: apply to individual lesions plus 5 mm surrounding healthy skin. For field-directed: apply to treatment field including skin between lesions plus 5 mm surrounding healthy area. Avoid mucous membranes (keep 1 cm distance). Allow to dry approximately 10 minutes before occlusion. 3. Occlusion: Cover with light-blocking occlusive dressing for 3 hours. Then remove dressing and wipe off remaining gel. 4. Illumination: Wear protective eyewear. Illuminate immediately after removing occlusion with BF-RhodoLED or RhodoLED XL lamp (red light, narrow spectrum around 635 nm, dose approximately 37 J/cm2). Calibration not needed; illumination time calculated automatically. Cooling with air or nebulized water may reduce pain. BF-RhodoLED: effective treatment area 6 x 16 cm, position lamp head 5-8 cm from skin. RhodoLED XL: curved, effective area up to 23 x 29 cm, position 11-14 cm from skin; full-face illumination usually with 5 panels, minimum 3 adjacent panels. Healthy untreated skin does not need protection during illumination.

If lesions cannot be illuminated within 3 hours after application, rinse off gel with saline and water. For 2 days, protect lesion sites and surrounding skin from sunlight or prolonged/intense light.

Retreat lesions that have not completely resolved 3 months after initial treatment.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Refer to Warnings and Precautions (5.3) for eye protection during illumination. Refer to Warnings and Precautions (5.7) for accidental contact with mucous membranes. No contraindications are listed in the provided label text.

Place in Therapy

Ameluz provides a topical photodynamic therapy option for lesion-directed and field-directed treatment of mild-to-moderate actinic keratoses on the face and scalp. It is administered by health care providers in combination with a specific red light lamp. The label does not provide comparative efficacy or long-term outcome data.

The FDA has approved a new treatment called Ameluz for actinic keratoses, or AKs, on the face and scalp. AKs are rough, scaly patches caused by years of sun exposure. They are not cancer, but they are considered a warning sign because they can sometimes develop into a type of skin cancer. Ameluz is a gel that a health care provider applies to the skin. Then a special red light shines on the area. This combination is called photodynamic therapy. The light helps the gel destroy the damaged skin cells.

This treatment is for adults with mild to moderate AKs. It can be used on specific spots or on a larger area of skin. The approval gives doctors another choice for treating these common skin problems. The treatment is done in a clinic or doctor's office. It is not something you use at home.

The approval does not include data from large patient trials in the label. That means the full picture of how well it works compared to other treatments may not be available yet. If you have rough, scaly patches on your face or scalp, talk to your doctor. They can help you decide if this treatment is right for you.

What this means for you:

A new gel plus red light treatment is approved for sun-damaged skin patches on the face and scalp. Ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedMay 2016

View Original Abstract ↓

1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AMELUZ, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED or RhodoLED XL lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses (AK) of mild-to-moderate severity on the face and scalp ( 1 ).

FDA approved Ameluz (aminolevulinic acid) for Actinic Keratoses of the Face and ScalpFDA approved New Gel and Light Treatment for Sun Damage on Face and Scalp

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