E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammation after IPL-treatment in patients with facial telangiectasias |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation after IPL-treatment in patients with facial vascular lesions |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043189 |
E.1.2 | Term | Telangiectasia |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
We aim at investigating, whether topical brimonidine can reduce IPL- induced post-inflammatory response in terms of erythema, oedema and pain in patients with facial telangiectasias. |
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E.2.2 | Secondary objectives of the trial |
1) IPL-induced treatment efficacy on telangiectasias with and without application of brimonidine 2) Patient-evaluated subjective discomfort and pain in the treatment area 3) Overall patient satisfaction
Secondary efficacy endpoints regarding point 1 are quantified by blinded photo-evaluation obtained with a Visia camera, in which baseline-photos are compared to photos from the final follow-up visit. Point 2 and 3 are evaluated on two separate 0-10 points Visual Analogue Scales (VAS) on discomfort/pain and patient satisfaction, respectively. Patient satisfaction is further evaluated in patient diaries |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with moderate to severe facial telangiectasias referred to laser or IPL-treatment. Severity and distribution of telangiectasias must be symmetrical between left and right side of the face in the individual patient • Telangiectasias may be observed in connection with rosacea, but rosacea must not demonstrate clinical active inflammation or acne • 18-65 years of age • Fitzpatrick skin type I-III • Fertile women must document non-reactive urine pregnancy test at the day of inclusion • During the study, fertile women must be using effective birth control.Effective contraception is defined as follows: o Hormonal contraceptive (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) o Intrauterine device; o Trans-abdominal surgical sterilization; o Sterilization implant device; o Surgical sterilization of male partner (given that the subject is monogamaous); • Verbal and written consent to participate in the study • Documentation of medicine status |
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E.4 | Principal exclusion criteria |
• Clinical active dermatological disease in the face • Wounds, dermatitis, tattoos or scars in treatment area • Allergies to ingredients in Mirvaso • Current treatment with monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants which interacts with the noradrenergic transmission • Current treatment with other systemic adrenergic receptor agonists or antagonists • Patients with known liver or renal disease • UV-exposure (solarium or sunbathing) or other treatment within the last month that enhances skin pigmentation • Use of other topical agents that may interact with treatment • Local or systemic treatment with photosensitizing drugs • Pregnancy and breastfeeding women • Current participation in other clinical trials • Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions |
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate whether topical brimonidine can reduce IPL-induced inflammatory response |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At treatment 1,2 and 3 (scheduled with 3-weeks intervals) and at the first follow-up visit (one day after first treatment) |
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E.5.2 | Secondary end point(s) |
1) IPL-induced treatment efficacy on telangiectasias with and without application of brimonidine 2) Patient-evaluated subjective discomfort and pain in the treatment area 3) Overall patient satisfaction |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At treatment 1,2 and 3 (scheduled with 3-weeks intervals), at the first follow-up visit (one day after first treatment) and final follow-up visit (1 month after final treatment) and through patient diaries |
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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 | No |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Blinded evaluation and this is a split-face study, where patients are their own control |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Patients are their own control, and control in this receive no treatment (only IPL+air-cooling) |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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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Final follow-up visit 1 month after final treatment |
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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 | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |