Creams With or Without Urea Influence the Hydration of the Skin of the Foot

NCT03932747 | Completed DMC

• 1 other identifier: EXAMPLE-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The skin is the most external organ of our body and one of its main functions is to provide protection in terms of possible infections. Hydration is related to the proper functioning of the skin, being more difficult the appearance of wounds or cracks, which lead to the appearance of infections or other dermatological alterations. The skin of the feet is thicker than in the rest of the body, due to the load it supports, being more complicated to maintain it. With this study what is intended is to assess the effectiveness of different concentrations of urea (5% and 20%) in the hydration of the foot

Conditions

FOOT

Keywords

Hydration; UREA

Outcome Measures

Primary Outcomes (5)

• Pre-hydration of the study areas

  Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel). The measure that the corneometer gives us is UA (water per mg stratum corneum)

  5 minutes

• Pre and Post of all study areas

  Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel) after the application of the different creams. The measure that the corneometer gives us is UA (water per mg stratum corneum).

  5 MINUTES

• Comparison of hydration of study areas in placebo vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)

  It is compared if the hydration of the different study areas depending on the type of cream that has been used.

  3 hours after the application

• Comparison of hydration of study areas in placebo vs. 20% groups as determined using corneometer UA (water per mg stratum corneum)

  It is compared if the hydration of the different study areas depending on the type of cream that has been used.

  3 hours after the application

• Comparison of hydration of study areas in 20% vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)

  It is compared if the hydration of the different study areas depending on the type of cream that has been used.

  3 hours after the application

Study Arms (3)

Placebo Creams

PLACEBO COMPARATOR

Measuring the skin before the application of the cream without urea (placebo), wait 3 hours and re-measure the hydration

Other: pre- Hydratión skin; Other: post- Hydratión skin

Urea 5%

ACTIVE COMPARATOR

Measuring the skin before the application of the cream with urea (5%), wait 3 hours and re-measure the hydration

Other: pre- Hydratión skin; Other: post- Hydratión skin

Urea 20%

ACTIVE COMPARATOR

Measuring the skin before the application of the cream with urea (20%), wait 3 hours and re-measure the hydration

Other: pre- Hydratión skin; Other: post- Hydratión skin

Interventions

pre- Hydratión skin OTHER

Measurement of hydration of the skin.

Placebo Creams; Urea 20%; Urea 5%

post- Hydratión skin OTHER

Measurement of hydration of the skin.

Placebo Creams; Urea 20%; Urea 5%

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• those people who want to voluntarily participate in the study.

You may not qualify if:

• suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb
• who do not fall within the age range of the study
• who have used creams or any type of lotion the night before on the feet

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Centro Universitario de Plasencia

Plasencia, Cáceres, 10600, Spain

Location

Study Officials

• BEATRIZ GOMEZ MARTIN, PODOLOGÍA

  CENTRO UNIVERSITARIO DE PLASENCIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: CLINICAL TRIAL WITH THREE GROUPS: CONTROL GROUP, UREA GROUP 5% AND UREA GROUP 20%.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 1, 2019
• Study Start: January 10, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)