Clinical trial · Interventional
Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
- 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)
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hand held liquid nitrogen spray cryotherapy | Procedure | — | UNRESOLVED |
| Metvix® cream | Drug | Methyl Aminolevulinate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metvix® PDT
- description
- Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
- interventionNames
- Drug: Metvix® cream
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy
- description
- Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks.
- interventionNames
- Procedure: Hand held liquid nitrogen spray cryotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: A participant with superficial BCC lesion(s) suitable for entry was defined as a participant with: * histologically confirmed diagnosis of primary superficial BCC lesion(s) * BCC lesions suitable for cryotherapy * males or females above 18 years of age * written informed consent. In accordance with Amendment 2 (local amendment), only participant above 19 years of age were to be included in Austria. Exclusion Criteria: A participant or lesion fulfilling any of the following criteria was ineligible for inclusion: * prior treatment of the BCC lesion(s) * participant with more than 10 eligible BCC lesions * a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk * a superficial BCC lesion with the largest diameter smaller than 6 mm * participant with porphyria * participant with Gorlin's syndrome * pigmented superficial BCC lesion(s) * morpheaform lesion(s) * infiltrating lesion(s) * participants with a history of arsenic exposure * known allergy to Metvix®, a similar PDT compound or excipients of the cream * participation in other clinical studies either concurrently or within the last 30 days * pregnant or breast-feeding; all women of child-bearing potential had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter * conditions associated with a risk of poor protocol compliance. In Amendment 1 the following exclusion criteria were added: * xeroderma pigmentosum lesion * concurrent use of immunosuppressive medication.
References
Publications (0)
Data not yet available