ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 32 for:    Chroma

Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02764411
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Brief Summary:

Capillary Malformations (CM) affect a significant proportion of otherwise healthy children and may lead to psychological discomfort if left untreated. A significant proportion of untreated lesions undergo soft tissue thickening and darker discoloration later in life due to progressive ectasia of the affected vessels. While laser treatment is available, its use may be limited due to need for repeated sedation/general anesthetic use, partial response and cost.

The investigators propose to conduct an open-label, prospective, cohort study using Onreltea ( Brimonidine) gel for treatment of facial capillary malformations in children. The study medication will be applied topically on affected area of the skin daily for 12 weeks. Follow up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the proposed treatment.

The study second aim is to explore the feasibility of conducting a multicenter placebo controlled study.


Condition or disease Intervention/treatment Phase
Capillary Malformations Drug: Brimonidine 0.33% gel Phase 3

Detailed Description:

The investigators are planning to enroll in the study 20 participants at SickKids.

It is a prospective, open label, cohort study. Patients enrolled in the study will be followed at the Hospital For Sick Children for 16 weeks. They will come for the study visits 6 times: in 1 week, 4,8,12, and 16 weeks after the treatment has been started. During each study visit the study investigators will assess any changes in the characteristics of CM lesion(s) captured by a Chromometer *, Analogue Scale and Erythema Assessment tools. Participants or their parents will assess the changes at the final study visit (VAS and EA tools).

Patients will be provided with study medication for all duration of the study treatment (12 weeks).

The results of the treatment will be compared with the baseline data to evaluate the efficacy and safety of Onreltea (Brimonidine) gel in children with facial capillary malformations.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations: A Prospective, Open-label, Cohort Study
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Onreltea ( Brimonidine)
All the patients enrolled in the study will apply Onreltea ( Brimonidine 0.33%) gel on the affected skin area for 12 weeks (from Day 0 to Week 12 visit).
Drug: Brimonidine 0.33% gel
Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks
Other Name: Onreltea




Primary Outcome Measures :
  1. The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks. [ Time Frame: 12 weeks ]
    Measurement of erythema will be performed using Chroma Meter, CR-400, Konica, Minolta, Osaka, Japan. The meter readings will result in 3 values: L- refers to the relative light intensity, ranging from 0 (black) to +100 (white); a-captures color saturation, ranging from +60 (green) to -60 (red) and b- captures color spectrum from +60 (blue) to -60 (yellow). In most studies both, changes in a (Δa) and overall changes in the composite score (ΔE calculated as √((ΔL*before-ΔL*after)^2+(Δa*before-Δa*after)^2+(Δb*before-ΔL*after)^2 ) are obtained.


Secondary Outcome Measures :
  1. Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline [ Time Frame: 1,4,8,16 weeks ]
    Same as in primary outcome measure

  2. Changes in CEA scores at 12, 16 weeks compared to baseline [ Time Frame: 12 and 16 weeks ]

    A Clinician Erythema Assessment scale (CEA), consisting of a 0-4 numerical scale as follows:

    0- clear skin, no erythema

    1. almost clear skin, slight redness
    2. mild erythema, definite redness
    3. moderate erythema, marked redness
    4. severe erythema, fiery redness

  3. Changes in the iVAS at 12 and 16 weeks compared to baseline [ Time Frame: 12 and 16 weeks ]
    Investigator's assessment of changes on the Visual Analogue Scale ( iVAS)

  4. Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values [ Time Frame: 1,4,8,12,16 weeks ]
    pVAS - patient/parent's Visual Analogue Scale assessment; pEA- patient/parent Erythema Assessment

  5. Percentage of patients achieving 75% and 100% resolution of the lesion [ Time Frame: 12 weeks ]
    by iVAS and chromo meter values

  6. Frequency of observed and reported adverse events (AE) [ Time Frame: 16 weeks ]
    AE documented in patient diary and mentioned at each study visit


Other Outcome Measures:
  1. Predictors for a good response, defined as at least 50 % change in the erythema measured using Chroma Meter (a* after compared to a* before) at 12 weeks mark [ Time Frame: 12 weeks ]
    Predictors for a good response, defined as at least 50 % change in the erythema measured using Chroma Meter (a* after compared to a* before) at 12 weeks mark. Percent of participants with predictors for a good response.

  2. Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control) [ Time Frame: 1,4,8,12 and 16 weeks ]

    Changes in value ( e.g. "a") between baseline and Week *, calculated in % for investigational lesion, minus changes in value "a" between baseline and Week * , calculated in % for the control lesion.

    (a (inv.Week*) - a (inv. Baseline)/ a (inv. Baseline)) x 100% -- (a (contr. Week*) - a (contr. Baseline)/ a ( contr. baseline)) x 100%


  3. Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks) [ Time Frame: 16 weeks ]
    Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of facial capillary malformation (port-wine stain, PWS) made by a dermatologist
  • age: 12-17 years of age
  • weight > 45 kg
  • lesions with a surface area < 100 cm2
  • signed consent and assent for study participation

Exclusion Criteria:

  • skin breakdown overlying the malformation due to other dermatological conditions (e.g. eczema, psoriasis)
  • current or treatment with laser the past 3 months
  • other topical treatments used within the past 4 weeks (e.g. rapamycin, corticosteroids, calcineurin inhibitors, etc)
  • known chronic renal or hepatic disorders
  • known cardiovascular disorders
  • other systemic medications that potentially interact with Brimonidine (opiates, chlorpromazine, methyphenidate, reserpine, etc)
  • mixed capillary/ venous or lymphatic malformations
  • known allergy to one of the constituents of Onreltea
  • pregnancy, or sexually active subjects of child-bearing potential (CBP), unwilling to use contraception during the study (such as barrier method, or oral contraceptives).

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): NCT02764411


Contacts
Contact: Elena Pope, MD 416-813-6883 Elena.Pope@sickkids.ca
Contact: Irene Lara-Corrales, MD 416-813-4864 Irene.Lara-Corrales@sickkids.ca

Locations
Canada, Ontario
The Hospital For Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Elena Pope, MD    416-813-7835    Elena.Pope@sickkids.ca   
Contact: Hanna Fadzeyeva    416-813-7835    Hanna.Fadzeyeva@sickkids.ca   
Sub-Investigator: Irene Lara Corrales, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Galderma Laboratories, L.P.
Investigators
Principal Investigator: Elena Pope, MD The Hospital for Sick Children

Responsible Party: Elena Pope, Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology., The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02764411     History of Changes
Other Study ID Numbers: 1000051364
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elena Pope, The Hospital for Sick Children:
Capillary malformations
Onrealtea
port-wine stain
treatment
topical

Additional relevant MeSH terms:
Congenital Abnormalities
Port-Wine Stain
Vascular Malformations
Skin Abnormalities
Skin Diseases
Cardiovascular Abnormalities
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