Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721185
• Other study ID #: BCE24918
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diet Modification
• Lipolysis
• Obesity
• Overweight
• Overweight and Obesity
• Physical Activity

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