actinic keratoses and photoaged skin MedDRA version: 12.0 Level: LLT Classification code 10000614 Term: Actinic keratosis MedDRA version: 12.0 Level: LLT Classification code 10065944 Term: Photodamaged skin
Conditions
Interventions
Trade Name: Metvix
Pharmaceutical Form: Cream
CAS Number: 79416-27-6
Current Sponsor code: Metvix
Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE
Concentration unit: mg/g milligram(s)/gra
Sponsors
Free State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Written informed consent has been signed prior to or at Screening Visit ? Caucasian male and female patients ? Age > 18 years ? Clinical diagnosis of actinic keratosis (AK) ? One to four separated AK lesions of mild to moderate grade* with clearly defined margins located on the dorsum of the hand ? Glogau Photodamage Classification Type III and IV *Mild grade (I): Flat, pink maculae or patch on sun-damaged skin, background mottling, no roughness or hyperkeratosis. Moderate grade (II): Pink to red papule or plaque with rough, hyperkeratotic surface, variable induration 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? - PDT non-responder ? - Diagnosis of porphyria ? - More than four separated AK lesions on each dorsum of the hand ? - Pregnancy or lactation ? - Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) ? - Skin diseases that might interfere with response evaluation of study treatment ? - Skin sun sensitivity type V or VI according to Fitzpatrick ? - Non-permitted medication: ? - - Topical pre-treatment of the AK study lesions with 5-ALA-PDT, Metvix®-PDT, Solaraze®, Aldara®, 5-FU, polyphenon E or vitamin A derivatives containing formulations during the 4 weeks preceding study treatment ? - - Topical pre-treatment of the AK study lesions during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulation ? - - Systemic treatment with retinoids during the 3 months preceding study therapy ? - - Systemic treatment with cytostatic drugs or radiation therapy performed in the treatment area during the 3 months preceding study therapy ? - Known intolerance to one or more of the ingredients of MAL ? - Conditions that might interfere with the ability to understand the study and thus give written informed consent ? - Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusionSuspected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The rationale of this study is to evaluate the efficacy of repetitive PDT for the treatment of AK and photodamage on the dorsum of the hands. ? - Assessment of the efficacy of IPL-PDT with MAL in the treatment of mild to moderate AK located on the dorsum of the hands ? - Histologic assessment of accession of newly formed subepidermal collagen ;Secondary Objective: ? - Assessment of efficacy on lesion basis after the last treatment ? - Assessment of the tolerability of IPL-PDT ? - Assessment of cosmetic outcome after any IPL-PDT ? - Assessment of ultrastructural and immunohistochemical changes following IPL-PDT ? - Assessment of patient satisfaction scores ;Primary end point(s): The primary endpoint is the Complete Clinical Clearance on patient basis after the second PDT session. Complete Clinical Clearance is assessed by clinical examination and may be diagnosed in the absence of clinical manifestations of AK in the preassigned sites. The second primary endpoint is accession of newly formed subepidermal collagen after the second PDT session. The determination of the thickness of subepidermal neocollagen formation will be done by histographic thickness measurement analyzing the respective skin biopsy. | — |
Countries
Germany
Outcome results
None listed