Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

October 24, 2018 updated by: BiomediKcal

Efficacy of a Lipolytic Cream in the Body Composition of an Overweight and Obesity Treatment

The coadyouvant efficacy of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The coadyouvant efficacy and safety of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients of both gender and different age groups. DESIGN: In a monocenter, open-label, randomized, parallel-group study of 102 patients that consulted for overweight and obesity treatment were analyzed in perimeters and body composition for 12 consecutive weeks that were medically prescribed a weekly hypocaloric diet and physical activity for one group of 51 patients, and hypocaloric diet, physical activity and the lypolitic cream at least twice per day for the other group of 51 patients. Efficacy was evaluated by comparing intial and final of all values in both groups. Safety was monitored by the incidence of adverse events. Patients also assessed the acceptability of the cream presentation.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight and obesity treatment voluntary assistance

Exclusion Criteria:

  • Hearth disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LC
Lypolitic cream with hypocaloric diet and physicial activity in 51 patients
Combination product: Dr.K. Treatment
Overweight and obesity treatment response
PLACEBO_COMPARATOR: NLC
Hypocaloric diet and physicial activity alone in 51 patients
Combination product: Dr.K. Treatment
Overweight and obesity treatment response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body composition with a scientific impedanciometer
Time Frame: Baseline and weeks: 1, 4, 8, 12,16
Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)
Baseline and weeks: 1, 4, 8, 12,16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perimeters measured with measuring tape
Time Frame: Baseline and weeks: 1, 4, 8, 12,16
Variation in the perimeters in centimeters in waist, hip, thigh and arm.
Baseline and weeks: 1, 4, 8, 12,16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BiomediKcal

Collaborators

Universidad Miguel Hernandez de Elche
University of Alicante
Universidad Simón Bolívar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

September 21, 2018

Study Completion (ACTUAL)

September 23, 2018

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (ACTUAL)

October 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCE24918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous patient information will be shared only if requested and justified in writing by researchers. It will be evaluated in committee if it is a justified request.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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