Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

Capillary Malformations Clinical Trial

Official title:

Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations: A Prospective, Open-label, Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02764411
• Other study ID #: 1000051364
• Status: Terminated
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Capillary Malformations
• Congenital Abnormalities
• Vascular Malformations

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital For Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Galderma Laboratories, L.P.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	The change in the color of the capillary malformation using Chroma meter values (?a, ?E) 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 (?a) and overall changes in the composite score (?E calculated as v((?L*before-?L*after)^2+(?a*before-?a*after)^2+(?b*before-?L*after)^2 ) are obtained.	12 weeks
Secondary	Changes in the color of the lesion (?a, ?E) 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
Secondary	Changes in CEA scores at 12, 16 weeks compared to baseline	A Clinician Erythema Assessment scale (CEA), consisting of a 0-4 numerical scale as follows: 0- clear skin, no erythema; almost clear skin, slight redness; mild erythema, definite redness; moderate erythema, marked redness; severe erythema, fiery redness	12 and 16 weeks
Secondary	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
Secondary	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
Secondary	Percentage of patients achieving 75% and 100% resolution of the lesion	by iVAS and chromo meter values	12 weeks
Secondary	Frequency of observed and reported adverse events (AE)	AE documented in patient diary and mentioned at each study visit	16 weeks