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Poor enrollment, lack of feasibility
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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine 0.33% gel | Drug | Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline | Same as in primary outcome measure | 1,4,8,16 weeks |
| Changes in CEA scores at 12, 16 weeks compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Pope, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital For Sick Children | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Term |
|---|---|
| C562760 | Capillary Malformations, Congenital, 1 |
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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A Clinician Erythema Assessment scale (CEA), consisting of a 0-4 numerical scale as follows:
0- clear skin, no erythema
| 12 and 16 weeks |
| Changes in the iVAS at 12 and 16 weeks compared to baseline | Investigator's assessment of changes on the Visual Analogue Scale ( iVAS) | 12 and 16 weeks |
| Correlation between iVAS, pVAS, CEA, pEA and Chroma Meter values | pVAS - patient/parent's Visual Analogue Scale assessment; pEA- patient/parent Erythema Assessment | 1,4,8,12,16 weeks |
| Percentage of patients achieving 75% and 100% resolution of the lesion | by iVAS and chromo meter values | 12 weeks |
| Frequency of observed and reported adverse events (AE) | AE documented in patient diary and mentioned at each study visit | 16 weeks |
| Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control) | 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% | 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) | Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks) | 16 weeks |
| D017437 | Skin and Connective Tissue Diseases |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |