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Photodynamic therapy with topical methyl aminolevulinate for solar keratosis in organ transplant recipients: Ways to improve treatment

Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis in organ transplant recipients: Methods to improve treatment - MAL-PDT for actinic keratosis in OTR: ways to improve treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002233-11-DK
Enrollment
Unknown
Registered
2012-06-19
Start date
2012-07-11
Completion date
Unknown
Last updated
2012-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

actinic keratosis

Interventions

Trade Name: Metvix Creme Product Name: Metvix creme Product Code: na Pharmaceutical Form: Cream INN or Proposed INN: methyl aminolevulinate hydrocloride CAS Number: 79416-27-6 Current Sponsor code: NA

Sponsors

Bispebjerg Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: actinic keratosis organ transplant recipients stable immunosuppressive treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnant or lactating women allergy to metvix porphyria age under 18 years

Design outcomes

Primary

MeasureTime frame
Main Objective: Efficacy of Metvix treatment compared to Metvix treatment and pretreatment of the skin with ablative fractional laser;Secondary Objective: Safety of metvix PDT combined with pretreatment with ablative fractional laser;Primary end point(s): lesion response rate in the treatment area in each patient;Timepoint(s) of evaluation of this end point: 1 and 3 months after treatment—

Secondary

MeasureTime frame
Secondary end point(s): adverse events pain during illumination protoporphyrin ix accumulation and activation;Timepoint(s) of evaluation of this end point: immediate after treatment 1 nad 3 months after treatment—

Countries

Denmark

Contacts

Public ContactKatrine Togsverd-Bo

Bispebjerg Hospital

katrinetogsverd@hotmail.com004535316098

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026