Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

NCT ID: NCT03721185

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-09-23

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.

Conditions

Lipolysis; Overweight and Obesity; Diet Modification; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LC

Lypolitic cream with hypocaloric diet and physicial activity in 51 patients

Group Type: ACTIVE_COMPARATOR

Dr.K. Treatment

Intervention Type: COMBINATION_PRODUCT

Overweight and obesity treatment response

NLC

Hypocaloric diet and physicial activity alone in 51 patients

Group Type: PLACEBO_COMPARATOR

Dr.K. Treatment

Intervention Type: COMBINATION_PRODUCT

Overweight and obesity treatment response

Interventions

Dr.K. Treatment

Overweight and obesity treatment response

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Overweight and obesity treatment voluntary assistance

Exclusion Criteria

• Hearth disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alicante

OTHER

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

Universidad Simón Bolívar

OTHER

Sponsor Role: collaborator

BiomediKcal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 26082579 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21284660 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17441853 (View on PubMed)

Other Identifiers

BCE24918

Identifier Type: -

Identifier Source: org_study_id