Clinical trial NCT03721185: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lipolysis
Overweight and Obesity
Diet Modification
Physical Activity
Keywords: obesity
overweight
fat percentage
body fat
lipolytic cream
Lead sponsor: BiomediKcal
Sponsor class: OTHER
Collaborators: name: University of Alicante
name: Universidad Miguel Hernandez de Elche
name: Universidad Simón Bolívar
First posted: 2018-10-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, randomized, parallel-group
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Overweight and obesity treatment voluntary assistance

Exclusion Criteria:

* Hearth disease

Primary outcomes:
measure: Change in body composition with a scientific impedanciometer
timeFrame: Baseline and weeks: 1, 4, 8, 12,16
Secondary outcomes:
measure: Change in perimeters measured with measuring tape
timeFrame: Baseline and weeks: 1, 4, 8, 12,16
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.