Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

NCT02764411 | Terminated Phase 3

• 1 other identifier: 1000051364
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Capillary Malformations

Keywords

Capillary malformations; Onrealtea; port-wine stain; treatment; topical

Outcome Measures

Primary Outcomes (1)

• The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 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.

  12 weeks

Secondary Outcomes (6)

• Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline

  1,4,8,16 weeks

• Changes in CEA scores at 12, 16 weeks compared to baseline

  12 and 16 weeks

• Changes in the iVAS at 12 and 16 weeks compared to baseline

  12 and 16 weeks

• Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values

  1,4,8,12,16 weeks

• Percentage of patients achieving 75% and 100% resolution of the lesion

  12 weeks

Other Outcomes (3)

• 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

  12 weeks

• Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control)

  1,4,8,12 and 16 weeks

• Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)

  16 weeks

Study Arms (1)

Onreltea ( Brimonidine)

EXPERIMENTAL

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

Interventions

Brimonidine 0.33% gel DRUG

Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks

Also known as: Onreltea

Onreltea ( Brimonidine)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Galderma R&D: collaborator

Study Sites (1)

The Hospital For Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1; Port-Wine Stain

Interventions

Brimonidine Tartrate; Gels

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Elena Pope, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology.

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)