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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

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Detailed Description:

Study design The study is designed as a dual-centre, randomized, intra-individual, split-face clinical controlled trial with blinded outcome assessment. A total of 20 patients with moderate to severe facial telangiectasias, without other clinical active dermatological disease in the skin, will be included. Severity and distribution (cheek, nose and chin) of telangiectasias must be symmetrical between facial sides in the individual patient at inclusion. All patients will receive IPL-treatments to both sides of the face. Before the first IPL-treatment, the left and right side of the face will be randomized to either brimonidine (Mirvaso) or only IPL-treatment and air-cooling (control), respectively. The study is conducted in an international collaboration between Bispebjerg Hospital, Department of Dermatology in Denmark and "Skinperium" private practice in Belgium.

Interventions Patients are asked to attend 3 treatment days and 2 follow-up visits. Treatment days are planed with 3 weeks intervals (± 5 days) and follow-up visits are planned at trial day 2 (one day after treatment day 1) and at 1 month (± 5 days) after the final treatment day. The consultations are estimated to last between half an hour and two hours. Patients are further asked to fill out patient diaries in the first 6 days after follow-up visit at trial day 2.

At each treatment day, patients receive 1) IPL of their whole face, 2) brimonidine is thereafter applied to the facial side randomized to treatment followed by 3) air-cooling, which is applied to the whole face of the patient in accordance with clinical guidelines.

Efficacy endpoints & evaluation methods

Primary efficacy endpoint:

To investigate whether topical brimonidine can reduce IPL-induced inflammatory response

Secondary efficacy endpoints:

  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

Primary efficacy endpoint is quantified by reduction in erythema and oedema assessed by blinded clinical on-site evaluation and by blinded photo-evaluation.

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 point Visual Analogue Scales (VAS) on discomfort/pain and patient satisfaction, respectively. Patient satisfaction is further evaluated in patient diaries.

Product Mirvaso® (brimonidine tartrate (3,3mg/1g), Galderma Nordic) One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.

Excipient(s) with known effect:

One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol.

Other excipients:

  • Carbomer Methylparahydroxybenzoate (E218) Phenoxyethanol
  • Glycerol
  • Titanium dioxide
  • Propylene glycol
  • Sodium hydroxide
  • Purified water

Statistic analysis Primary efficacy endpoint is difference in inflammation between brimonidine vs. control.

Wilcoxon signed-rank test will be used for paired comparison to evaluate eventual differences between brimonidine vs. control. Analysis on Per-Protocol will only include the patients completing the study according to protocol.

Sample size Estimation of sample size is based on clinical on-site evaluation on inflammation 30 minutes after incubation of brimonidine (effect of brimonidine is evident after 30 minutes cf.´Summary of Product Characteristics) and 24 hours after application.

With a power of 90%, a type I error probability of 5% and an estimated standard deviation of 25%, we should include 17 patients to detect a minimum relevant difference (MIREDIF) of 20% between brimonidine and control. We choose a 20% MIREDIF, since a reduction in inflammation <20%, based on a resource economic point of view is considered clinical irrelevant. Based on earlier experience and duration of the trial, a 15% dropout rate should be taken into account and therefore, a total of 20 patients will be included.


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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.



Information from the National Library of Medicine

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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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Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Brimonidine Tartrate
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