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Trial record 3 of 155 for:    Brimonidine

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

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ClinicalTrials.gov Identifier: NCT02761174
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Skinperium, Christine Dierickx
Ellipse A/S Agern Allé 11, 2970 Hørsholm
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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.


Condition or disease Intervention/treatment Phase
Telangiectasias Drug: Brimonidine Other: IPL+air-cooling Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias
Actual Study Start Date : March 13, 2016
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : January 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Brimonidine (Mirvaso cream)
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
Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control
Other Name: Mirvaso cream

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




Primary Outcome Measures :
  1. Reduction in erythema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation. [ Time Frame: Throughout the study, a period of 10 weeks ]

    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

  2. Reduction in oedema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation. [ Time Frame: Throughout the study, a period of 10 weeks ]
    Oedema is evaluated on a 4-point scale: 0 = no oedema, 1 = little oedema, 2 = moderate oedema and 3 = severe oedema.


Secondary Outcome Measures :
  1. 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. [ Time Frame: At the end of the study (after 10 weeks) ]
    Baseline photos are compared to photos at final follow-up visit approximate 10 weeks after.

  2. Patient discomfort and pain [ Time Frame: Throughout the study, a period of 10 weeks ]
    Patient discomfort and pain are evaluated on a numeric Visual Analogue Scale (VAS) from 0 (no discomfort/pain) to 10 (extreme discomfort/pain) separately for brimonidine and control

  3. Patient overall satisfaction [ Time Frame: Throughout the study, a period of 10 weeks ]
    Patients evaluate their overall satisfaction with brimonidine to reduce IPL-induced inflammation on a numeric VAS from 0 (poor outcome) to 10 (excellent outcome). Inflammation is described as redness, swelling and pain to the patient.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761174


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2200
Sponsors and Collaborators
Merete Haedersdal
Skinperium, Christine Dierickx
Ellipse A/S Agern Allé 11, 2970 Hørsholm
Investigators
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Principal Investigator: Merete Hædersdal, Prof., MD Department of Dermatology

Additional Information:
Publications:

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Responsible Party: Merete Haedersdal, Professor, MD, DMSc, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02761174     History of Changes
Other Study ID Numbers: 2015-004789-27
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sponsor and investigator allow access to registries, CRF and trial master files in case of audit or quality inspection from relevant authorities such as GCP-unit, Danish Health and Medicine Authority or The Regional Committee on Health Research Ethics
Keywords provided by Merete Haedersdal, Bispebjerg Hospital:
Vascular lesions
inflammation
IPL
Additional relevant MeSH terms:
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Brimonidine Tartrate
Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs