Clinical trial · Interventional
Daylight-PDT With MAL for AK and Photodamaged Skin
Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Photodamaged Skin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryosurgery | Procedure | — | UNRESOLVED |
| Daylight photodynamic therapy using Methylaminolevulinate (MAL) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Daylight photodynamic therapy (PDT)
- description
- One intervention in the daylight photodynamic therapy arm: Daylight photodynamic therapy using Methylaminolevulinate (MAL) will be performed five times within 18 months (visits 1-5). In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and methylaminolevulinate (MAL) will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.
- interventionNames
- Drug: Daylight photodynamic therapy using Methylaminolevulinate (MAL)
- type
- ACTIVE_COMPARATOR
- label
- Cryosurgery
- description
- In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent has been signed prior to or at Screening Visit * Male and female patients with Fitzpatrick skin type I-IV * Age \> 40 years * Negative pregnancy test in women of childbearing age * Women in child-bearing age using highly efficient contraceptive methods (\<1% failure rate per year) * Clinical diagnosis of actinic keratosis (AK) * A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face. * Glogau Photodamage Classification Type II (moderate) - IV (severe) Exclusion Criteria: * Diagnosis of porphyria * Hyperkeratotic or pigmented AK in the face * Malignant skin tumors in the face or on the capillitium, requiring treatment * Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients * Pregnancy or lactation * Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing) * Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream * Known intolerance to Actinica® lotion * Photosensitivity * Suspected lack of compliance (e.g. due to dementia) * Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * Concomitant UV-phototherapy * Skin diseases that might interfere with response evaluation of study treatment * Skin sun sensitivity type V or VI according to Fitzpatrick * PDT in the face during 6 months preceding study treatment * Non-permitted medication: * Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator. * Systemic treatment with retinoids * Conditions that might interfere with the ability to understand the study and thus give written informed consent * Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL
References
Publications (1)
- DERIVEDKohl E, Koller M, Zeman F, Szeimies RM, Philipp-Dormston WG, Prager W, Gerber PA, Karrer S. Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study. BMC Dermatol. 2017 Oct 25;17(1):12. doi: 10.1186/s12895-017-0064-7. PMID 29070025