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Completed

NCT Number: NCT03721185

Efficacy of a Lipolytic Cream in 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.

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Key information

Conditions

Lipolysis Behavior Body Weight Diet Modification Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight and obesity treatment voluntary assistance

Exclusion criteria

  • Hearth disease

Treatment and study plan

Dr.K. Treatment

Combination Product

Overweight and obesity treatment response

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

BiomediKcal

Other

Collaborators

  • Universidad Miguel Hernandez de Elche
  • Universidad Simón Bolívar
  • University of Alicante

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2018
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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