Therapy-treatment (PDT) on Acne, a study to optimize the number of treatments, the right light-dose and the right pre-treatment in order to obtain a longterm remission-time

Therapy-treatment (PDT) on Acne, a study to optimize the number of treatments, the right light-dose and the right pre-treatment in order to obtain a longterm remission-time - PDTofAcne

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005235-13-SE

Enrollment

Registered

2014-12-12

Start date

2015-02-10

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

Acne MedDRA version: 17.1 Level: HLT Classification code 10000497 Term: Acnes System Organ Class: 100000004858

Interventions

Trade Name: Metvix cream Product Name: Metvix Pharmaceutical Form: Cream CAS Number: 33320-16-0 Other descriptive name: METHYL AMINOLEVULINATE Pharmaceutical form of the placebo: Cream Route of admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria Patients with papulopustular acne. Male or female between 18-25 years of age who has signed a written informed consent. 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 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant or breast-feeding. Patients who have been treated with tetracycline up to less than a month before PDT treatment. Local acne treatment until up to one week before PDT treatment. Conditions associated with poor protocol compliance, e.g. excessive use of alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame
Main Objective: To optimize PDT treatment in order to get a highly-tolerable dose without compromising, the already proven potent effect.;Secondary Objective: Comparing the 2 treatment regime with 4 treatments in terms of efficacy, length of remission and side effects. ;Primary end point(s): To get a PDT dose that is as effective as previously tested doses but with less pain and skin-reactions.;Timepoint(s) of evaluation of this end point: 20 weeks after last treatment.	—

Measure

Time frame

Main Objective: To optimize PDT treatment in order to get a highly-tolerable dose without compromising, the already proven potent effect.;Secondary Objective: Comparing the 2 treatment regime with 4 treatments in terms of efficacy, length of remission and side effects. ;Primary end point(s): To get a PDT dose that is as effective as previously tested doses but with less pain and skin-reactions.;Timepoint(s) of evaluation of this end point: 20 weeks after last treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): That the patients in the 4 treatment regime-group will have a better result than those in the 2 treatment-regime group.;Timepoint(s) of evaluation of this end point: 20 weeks after last treatment	—

Countries

Sweden

Contacts

Public ContactSahlgrenska dep. of dermatology

Sahlgrenska University hospital of gothenburg Department of dermatology

carin.sandberg@vgregion.se+46(0)313429415

Outcome results

None listed

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