Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment

NCT03721185 | Completed

• 1 other identifier: BCE24918
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lipolysis; Overweight and Obesity; Diet Modification; Physical Activity

Keywords

obesity; overweight; fat percentage; body fat; lipolytic cream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in perimeters measured with measuring tape

  Baseline and weeks: 1, 4, 8, 12,16

Study Arms (2)

LC

ACTIVE COMPARATOR

Lypolitic cream with hypocaloric diet and physicial activity in 51 patients

Combination Product: Dr.K. Treatment

NLC

PLACEBO COMPARATOR

Hypocaloric diet and physicial activity alone in 51 patients

Combination Product: Dr.K. Treatment

Interventions

Dr.K. Treatment COMBINATION_PRODUCT

Overweight and obesity treatment response

LC; NLC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight and obesity treatment voluntary assistance

You may not qualify if:

• Hearth disease

Sponsors & Collaborators

• BiomediKcal: lead
• University of Alicante: collaborator
• Universidad Miguel Hernandez de Elche: collaborator
• Universidad Simón Bolívar: collaborator

Related 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.2015.27.3.243. Epub 2015 May 29.

  PMID: 26082579 RESULT

• 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.

  PMID: 21284660 RESULT

• 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.

  PMID: 17441853 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label, randomized, parallel-group

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 26, 2018
• Study Start: June 1, 2016
• Primary Completion: September 21, 2018
• Study Completion: September 23, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF