Inflammation after IPL-treatment in patients with facial telangiectasias MedDRA version: 18.1 Level: PT Classification code 10043189 Term: Telangiectasia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Mirvaso (brimonidine)
Product Name: Mirvaso
Product Code: D11AX21
Pharmaceutical Form: Cream
INN or Proposed INN: BRIMONIDINE
CAS Number: 59803-98-4
Concentration unit: mg/g milligram(s)/g
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion 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: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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;Primary end point(s): To investigate whether topical brimonidine can reduce IPL-induced inflammatory response;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Denmark
Contacts
Public ContactDermatologisk Afdeling
Bispebjerg Hospital
Outcome results
None listed