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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

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date January 5, 2018
Actual Study Start Date  ICMJE March 13, 2016
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02761174 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias
Official Title  ICMJE Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Telangiectasias
Intervention  ICMJE
  • 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
  • Other: IPL+air-cooling
    IPL+air-cooling are applied to the whole face and the control side thereby only receives IPL+air-cooling
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Brimonidine
  • 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).
    Intervention: Other: IPL+air-cooling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2018)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
20
Actual Study Completion Date  ICMJE January 13, 2017
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02761174
Other Study ID Numbers  ICMJE 2015-004789-27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party Merete Haedersdal, Bispebjerg Hospital
Study Sponsor  ICMJE Merete Haedersdal
Collaborators  ICMJE
  • Skinperium, Christine Dierickx
  • Ellipse A/S Agern Allé 11, 2970 Hørsholm
Investigators  ICMJE
Principal Investigator: Merete Hædersdal, Prof., MD Department of Dermatology
PRS Account Bispebjerg Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP