E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
actinic keratoses and photoaged skin |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065944 |
E.1.2 | Term | Photodamaged skin |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
- 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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irreversible damage to the skin by this procedure |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |