Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lipolysis, Overweight and Obesity, Diet Modification, Physical Activity

Intervention / Treatment
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* Combination Product: Dr.K. Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight and obesity treatment voluntary assistance Exclusion Criteria: Hearth disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label, randomized, parallel-group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LC<br>Lypolitic cream with hypocaloric diet and physicial activity in 51 patients | Combination Product: Dr.K. Treatment<br>* Overweight and obesity treatment response<br>|
| Placebo Comparator: NLC<br>Hypocaloric diet and physicial activity alone in 51 patients | Combination Product: Dr.K. Treatment<br>* Overweight and obesity treatment response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition with a scientific impedanciometer | 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 | Variation in the perimeters in centimeters in waist, hip, thigh and arm. | Baseline and weeks: 1, 4, 8, 12,16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, fat percentage, body fat, lipolytic cream