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

NCT02761174 | Completed Phase 4 DMC

• 1 other identifier: 2015-004789-27
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Telangiectasias

Keywords

Vascular lesions; inflammation; IPL

Outcome Measures

Primary Outcomes (2)

• Reduction in erythema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.

  Erythema is evaluated on the international validated, "Clinician's Erythema Assessment" (CEA) 5-point scale: 0, Clear Clear skin with no signs of erythema 1. Almost clear Almost clear; slight redness 2. Mild Mild erythema; definite redness 3. Moderate Moderate erythema; marked redness 4. Severe Severe erythema; fiery redness

  Throughout the study, a period of 10 weeks

• Reduction in oedema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.

  Oedema is evaluated on a 4-point scale: 0 = no oedema, 1 = little oedema, 2 = moderate oedema and 3 = severe oedema.

  Throughout the study, a period of 10 weeks

Secondary Outcomes (3)

• The effect of brimonidine on IPL-efficacy quantified by blinded photo-evaluation obtained with a Visia camera, in which baseline-photos are compared to photos from the final follow-up visit.

  At the end of the study (after 10 weeks)

• Patient discomfort and pain

  Throughout the study, a period of 10 weeks

• Patient overall satisfaction

  Throughout the study, a period of 10 weeks

Study Arms (2)

Brimonidine (Mirvaso cream)

ACTIVE COMPARATOR

This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face (control) and 0.5 g of brimonidine (Mirvaso cream) to the randomized side of the face.

Drug: Brimonidine

IPL+air-cooling

OTHER

This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face and IPL+air-cooling (control) are thereby compared to IPL+air-cooling+brimonidine (Mirvaso cream).

Other: IPL+air-cooling

Interventions

Brimonidine DRUG

Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control

Also known as: Mirvaso cream

Brimonidine (Mirvaso cream)

IPL+air-cooling OTHER

IPL+air-cooling are applied to the whole face and the control side thereby only receives IPL+air-cooling

IPL+air-cooling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• Fitzpatrick skin type I-III
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merete Haedersdal: lead
• Skinperium, Christine Dierickx: collaborator
• Ellipse A/S Agern Allé 11, 2970 Hørsholm: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2200, Denmark

Location

Related Publications (27)

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Related Links

• European Medicines Agency

MeSH Terms

Conditions

Telangiectasis; Inflammation

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Merete Hædersdal, Prof., MD

  Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc, PhD

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: May 4, 2016
• Study Start: March 13, 2016
• Primary Completion: July 11, 2016
• Study Completion: January 13, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)