Trial Outcomes & Findings for Polidocanol Versus Glucose Treatment of Telangiectasia Trial (NCT NCT02657252)

NCT ID: NCT02657252

Last Updated: 2018-01-04

Results Overview

Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 115 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2018-01-04

Participant Flow

Some patients (n=17) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 17 more patients.

Unit of analysis: lower limbs

Participant milestones

Measure	Glucose An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.
Overall Study STARTED	57 57	58 58
Overall Study COMPLETED	47 47	51 51
Overall Study NOT COMPLETED	10 10	7 7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Polidocanol Versus Glucose Treatment of Telangiectasia Trial

Baseline characteristics by cohort

Measure	Glucose n=57 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose n=58 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=93 Participants	58 Participants n=4 Participants	115 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 10 • n=93 Participants	43.6 years STANDARD_DEVIATION 10 • n=4 Participants	42.2 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	57 Participants n=93 Participants	58 Participants n=4 Participants	115 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Brazil	57 Participants n=93 Participants	58 Participants n=4 Participants	115 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Only one lower limb submited to the treatment.

Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments

Outcome measures

Measure	Glucose n=47 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose n=51 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.
Change From Baseline in Extent of Telangiectasias	57.24 percent of change negative values Standard Deviation 22.69	76.08 percent of change negative values Standard Deviation 18.63

SECONDARY outcome

Timeframe: 2 months

Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.

Outcome measures

Measure	Glucose n=47 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose n=51 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.
Skin Hyperpigmentation	0.49 percentage of hyperpigmentation Interval 0.0 to 13.15	0 percentage of hyperpigmentation Interval 0.0 to 10.85

SECONDARY outcome

Timeframe: 1 week

Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.

Outcome measures

Measure	Glucose n=47 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose n=51 Participants An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.
Number of Participants With Deep Venous Thrombosis (DVT)	0 Participants	0 Participants

Adverse Events

Glucose

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Polidocanol With Glucose

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Glucose n=47 participants at risk An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Glucose: Sclerotherapy of telangiectasis in one lower limb.	Polidocanol With Glucose n=51 participants at risk An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb.
Skin and subcutaneous tissue disorders Hyperpigmentation	59.6% 28/47 • Right after two months post procedure Hyperpigmentation: Linear measure above the projection area of hyperpigmentation post procedure. The length of this line was provided by the Image J software (ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health)	41.2% 21/51 • Right after two months post procedure Hyperpigmentation: Linear measure above the projection area of hyperpigmentation post procedure. The length of this line was provided by the Image J software (ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health)

Additional Information

Dr. Matheus Bertanha

UPECLIN

Phone: +551438116305

Email: matheus.fameca@ig.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place