Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias

• Status: Completed
• Trial end date: 2017-01-13
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced inflammation in terms of redness, swelling and pain in patients with facial vascular lesions (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated one month after final IPL-treatment.

The hypothesis is that brimonidine, which has been proved effective in reduction of symptomatic erythema in patients with rosacea, also may have the ability to reduce IPL-induced erythema. Since the potential reduction in erythema is caused by vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merete Haedersdal
• Collaborators: Ellipse A/S Agern Allé 11, 2970 Hørsholm; Skinperium, Christine Dierickx
• Treatments: Brimonidine Tartrate

Criteria

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:

• Injectable, implantable or orally taken hormones;

• Intrauterine device;

• Trans-abdominal surgical sterilization;

• Sterilization implant device;

• Surgical sterilization of male partner;

• Complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study

• Verbal and written consent to participate in the study

• Documentation of medicine status

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