E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy skin on the upper back on 3 participants in study a and 12 participants in study b. |
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E.1.1.1 | Medical condition in easily understood language |
Healthy skin on the upper back on 3 participants in study a and 12 participants in study b. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 study comprises two parts: A) A pre-study including 3-4 healthy participants to determine the optimal duration of 5-ALA incubation to visualize PpIX fluorescence microscopy. B) The aim of study B is to assess the impact of i) TMI exposure and ii) a low- and high-viscosity vehicle formulation on 5-ALA-induced PpIX fluorescence at skin surface and skin biodistribution within skin layers. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Healthy participants above 18 years of age • Fitzpatrick skin type I-III and normal skin on the upper back • Fertile women with negative U-hCG and with use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring • Provided informed written consent
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E.4 | Principal exclusion criteria |
• No previous PDT or laser treatment within the past 6 months in the study areas • Pregnant or lactating women • Participants with known allergy to 5-ALA, lidocaine or any excipients to components in the vehicles • Considered unable to follow the study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is PpIX fluorescence intensity measured at skin surface and PpIX fluorescence intensity and biodistribution within skin, following TMI and topical 20% 5-ALA in a low viscosity vehicle and high viscosity vehicle. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At treatment day and within 6 months from study approval. |
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E.5.2 | Secondary end point(s) |
I. Histology tissue effects immediately after TMI: Punch skin biopsies obtained 3 hours after TMI, evaluating histologic changes in the epidermis and dermis from hematoxylin-eosin stained histology-slides. The micropores are evaluated on a standardized term of depth, size and form. II. Skin reactions to TMI: Clinically graded as edema, erythema, scaling, pustules and crusting on a 4-point categorical scale as none, mild, moderate and serve. III. Pain during TMI: Participant evaluated pain on a numerical rating scale (NRS) from 0-10 at 1-point increments; 0 being no perceivable pain and 10 being worst imaginable pain.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At treatment day and within 6 months from study approval. |
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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 | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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LVLS 1. June 2019. Recruitment to begin and study interventions: 1. March - 1. June 2019 End of Study: 1. October 2019 |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |