CompletedPhase 3

Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma

Austria, Belgium, Finland120 participantsStarted 1999-10-18

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle

Timeframe: 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months

Trial details

NCT IDNCT00469417

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2001-09-05

Results submitted2022-07-13

View on ClinicalTrials.gov More Superficial Basal Cell Carcinoma trials