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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03721185
Other study ID # BCE24918
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date September 23, 2018

Study information

Verified date October 2018
Source BiomediKcal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 23, 2018
Est. primary completion date September 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Overweight and obesity treatment voluntary assistance

Exclusion Criteria:

- Hearth disease

Study Design


Intervention

Combination Product:
Dr.K. Treatment
Overweight and obesity treatment response

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
BiomediKcal Universidad Miguel Hernandez de Elche, University of Alicante, University Simón Bolívar

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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