Brimonidine-cream to reduce redness, swelling and pain after IPL- treatment and effect on IPL-efficacy in patients with facial vascular lesions

Phase 1

• Conditions: Inflammation after IPL-treatment in patients with facial telangiectasias; MedDRA version: 18.1Level: PTClassification code 10043189Term: TelangiectasiaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2015-004789-27-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-08
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified