E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erythema after sun exposure in healthy volunteers |
|
E.1.1.1 | Medical condition in easily understood language |
Sunburn after sun exposure in healthy volunteers |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045745 |
E.1.2 | Term | Unspecified dermatitis due to sun |
E.1.2 | System Organ Class | 100000004858 |
|
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 |
Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.
|
Reduktion af erythem grad undersøgt med digital image analyse (Image J) efter behandling med melatonin/placebo før sol eksponering. |
|
E.2.2 | Secondary objectives of the trial |
Visual inspection of erythema using Frosch-Klingman scale.
Testing for primary hyperalgesi in the sunexposed area with Pin-Prick monofilaments. |
Visuel vurdering af erythemgrad i hht. Frosch-Klingman visuel skala.
Bestemmelse af primær hyperalgesi i det solbestrålede hudområde med Pin-Prick monofilamenter. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers of both sexes. Skintype 1-3 acording to Fitzpatrick skin type scale. No sun exposure on skin area tested in the study 4 weeks prior to the study. |
Raske forsøgpersoner af begge køn Hudtype 1-3 i hht. Fitzpatrick hudtype skala. Ingen soleksponering på det hudområde, der ønskes testet i studiet 4 uger før studiet start. |
|
E.4 | Principal exclusion criteria |
Active skindisease Pregnancy Previous malignant or pre malignant skin disease |
Aktiv hudsygdom Graviditet Tidligere malign eller premalign hudsygdom |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Erythema assessed by digital image analysis (Image J). |
Erythemgrad undersøgt ved digital image analyse (Image J) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before sun exposure+4,8,24 hours after sun exposure |
Umiddelbart inden sol eksponering+4,8,24 timer efter soleksponering |
|
E.5.2 | Secondary end point(s) |
Erythema assessed by visual score (Frosch-Klingman scale) Hyperalgesia assessed by mechanical stimulation with monofilament.
|
Erythemgrad vurderet visuelt (Frosch-Klingman skala) Hyperalgesi vurderet ved mekanisk stimulation med monofilament.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before sun exposure+4,8,24 hours after sun exposure. |
Umiddelbart inden sol eksponering+4,8,24 timer efter soleksponering. |
|
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 | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | Yes |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial days | 7 |