NCT01950026

Brief Summary

The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

Same day

First QC Date

July 3, 2013

Last Update Submit

September 21, 2013

Conditions

Body Temperature Changes

Keywords

skin temperatureethnic groupscryotherapy

Outcome Measures

Primary Outcomes (1)

  • changes in skin cooling

    It was verified skin temperature of the subject in the supine position with them prior to the application of cryotherapy during application (at 3, 5, 10, 15, 20, 25 min) and after the application retitrada ice and after 30 minutes of implementation. Measurements were obtained in degrees Celsius with an infrared thermometer brand CASON Model CA380 recorded in a collection daos elaborated by authors

    two months

Study Arms (4)

white

EXPERIMENTAL

cryotherapy application

Procedure: cryotherapy application

black

EXPERIMENTAL

cryotherapy application

Procedure: cryotherapy application

Brown

EXPERIMENTAL

cryotherapy application

Procedure: cryotherapy application

asian

EXPERIMENTAL

cryotherapy application

Procedure: cryotherapy application

Interventions

cryotherapy applicationPROCEDURE

* Height, weight and BMI verification * subjects in supine position after 20 minutes of resting * cryotherapy application by cold thermal bag (thermoGel brand) size P * 15-20 cm above the ASIS * temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil

Brownasianblackwhite

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • belong to ethnic groups requested

You may not qualify if:

  • suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Center of Universidade Paulista

São Paulo, São Paulo, 03421-000, Brazil

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mauricio C Lima, expert

    Paulista University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
expert

Study Record Dates

First Submitted

July 3, 2013

First Posted

September 25, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

BR(1)