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Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

Primary Purpose

Lipolysis, Overweight and Obesity, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dr.K. Treatment
Sponsored by
BiomediKcal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipolysis focused on measuring obesity, overweight, fat percentage, body fat, lipolytic cream

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight and obesity treatment voluntary assistance

Exclusion Criteria:

  • Hearth disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    LC

    NLC

    Arm Description

    Lypolitic cream with hypocaloric diet and physicial activity in 51 patients

    Hypocaloric diet and physicial activity alone in 51 patients

    Outcomes

    Primary Outcome Measures

    Change in body composition with a scientific impedanciometer
    Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)

    Secondary Outcome Measures

    Change in perimeters measured with measuring tape
    Variation in the perimeters in centimeters in waist, hip, thigh and arm.

    Full Information

    First Posted
    September 24, 2018
    Last Updated
    October 24, 2018
    Sponsor
    BiomediKcal
    Collaborators
    University of Alicante, Universidad Miguel Hernandez de Elche, Universidad Simón Bolívar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03721185
    Brief Title
    Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment
    Official Title
    Efficacy of a Lipolytic Cream in the Body Composition of an Overweight and Obesity Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    September 21, 2018 (Actual)
    Study Completion Date
    September 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BiomediKcal
    Collaborators
    University of Alicante, Universidad Miguel Hernandez de Elche, Universidad Simón Bolívar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipolysis, Overweight and Obesity, Diet Modification, Physical Activity
    Keywords
    obesity, overweight, fat percentage, body fat, lipolytic cream

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    open-label, randomized, parallel-group
    Masking
    None (Open Label)
    Masking Description
    Researchers assessed the efficacy of a lipolytic cream with hypocaloric diet and physical activity in the treatment of overweight and obesity. The control treatment was lypolitic cream with hypocaloric diet and physicial activity and hypocaloric diet and physicial activity alone. In total, 102 patients were recruited and allocated to treatment (51: lypolitic cream with hypocaloric diet and physicial activity and, 51: hypocaloric diet and physicial activity alone.
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LC
    Arm Type
    Active Comparator
    Arm Description
    Lypolitic cream with hypocaloric diet and physicial activity in 51 patients
    Arm Title
    NLC
    Arm Type
    Placebo Comparator
    Arm Description
    Hypocaloric diet and physicial activity alone in 51 patients
    Intervention Type
    Combination Product
    Intervention Name(s)
    Dr.K. Treatment
    Intervention Description
    Overweight and obesity treatment response
    Primary Outcome Measure Information:
    Title
    Change in body composition with a scientific impedanciometer
    Description
    Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)
    Time Frame
    Baseline and weeks: 1, 4, 8, 12,16
    Secondary Outcome Measure Information:
    Title
    Change in perimeters measured with measuring tape
    Description
    Variation in the perimeters in centimeters in waist, hip, thigh and arm.
    Time Frame
    Baseline and weeks: 1, 4, 8, 12,16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Overweight and obesity treatment voluntary assistance Exclusion Criteria: Hearth disease

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    26082579
    Citation
    Byun SY, Kwon SH, Heo SH, Shim JS, Du MH, Na JI. Efficacy of Slimming Cream Containing 3.5% Water-Soluble Caffeine and Xanthenes for the Treatment of Cellulite: Clinical Study and Literature Review. Ann Dermatol. 2015 Jun;27(3):243-9. doi: 10.5021/ad.2015.27.3.243. Epub 2015 May 29.
    Results Reference
    result
    PubMed Identifier
    21284660
    Citation
    Escudier B, Fanchon C, Labrousse E, Pellae M. Benefit of a topical slimming cream in conjunction with dietary advice. Int J Cosmet Sci. 2011 Aug;33(4):334-7. doi: 10.1111/j.1468-2494.2010.00630.x. Epub 2011 Feb 1.
    Results Reference
    result
    PubMed Identifier
    17441853
    Citation
    Salavert M, Amarger S, Le Bouedec MC, Roger H, Souteyrand P, D'incan M. Allergic contact dermatitis to guggul in a slimming cream. Contact Dermatitis. 2007 May;56(5):286-7. doi: 10.1111/j.0105-1873.2006.00885.x. No abstract available.
    Results Reference
    result

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    Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

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