LipolysisNCT03721185
Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment
A study testing Dr.K. Treatment in people with Lipolysis and Overweight and Obesity, run by BiomediKcal.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipolysis, Overweight and Obesity, Diet Modification
- What is being tested?
- Dr.K. Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 23 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight and obesity treatment voluntary assistance
Who cannot join
- Hearth disease
About this study
Official title: Efficacy of a Lipolytic Cream in the Body Composition of an Overweight and Obesity Treatment
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.
Read the 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.
- Being tested
- Dr.K. Treatment
- Keywords
- obesity, overweight, fat percentage, body fat, lipolytic cream
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr.K. TreatmentCombination product
Overweight and obesity treatment response
| Study group | Role | What they receive |
|---|---|---|
| LC | Active comparator | Lypolitic cream with hypocaloric diet and physicial activity in 51 patients Receives: Combination Product: Dr.K. Treatment |
| NLC | Placebo comparator | Hypocaloric diet and physicial activity alone in 51 patients Receives: Combination Product: Dr.K. Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition with a scientific impedanciometer
Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)
Measured: Baseline and weeks: 1, 4, 8, 12,16
Secondary outcomes (1)
Change in perimeters measured with measuring tape
Variation in the perimeters in centimeters in waist, hip, thigh and arm.
Measured: Baseline and weeks: 1, 4, 8, 12,16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Jun 2016
- Primary completion21 Sep 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LipolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, randomized, parallel-group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiomediKcal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alicante, Universidad Miguel Hernandez de Elche, Universidad Simón Bolívar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721185
- Sponsor's protocol ID
- BCE24918
- Status last verified
- Oct 2018
- First submitted
- 24 Sep 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous patient information will be shared only if requested and justified in writing by researchers. It will be evaluated in committee if it is a justified request.
Publications
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.
PubMed 26082579Escudier 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.
PubMed 21284660Salavert 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.
PubMed 17441853
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Lipolytic Cream in the Body Composition of an Overweight and Obesity Treatment
- ClinicalTrials.gov ID
- NCT03721185
- Acronym / sponsor ID
- BCE24918
- Keywords
- obesity, overweight, fat percentage, body fat, lipolytic cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BiomediKcalUniversity, hospital or other
- Collaborators
- University of Alicante, Universidad Miguel Hernandez de Elche, Universidad Simón Bolívar
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomized, parallel-group
| Arm | Type | Receives |
|---|---|---|
| LC | Active comparator | Combination Product: Dr.K. TreatmentLypolitic cream with hypocaloric diet and physicial activity in 51 patients |
| NLC | Placebo comparator | Combination Product: Dr.K. TreatmentHypocaloric diet and physicial activity alone in 51 patients |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight and obesity treatment voluntary assistance
Key exclusion criteria (1 listed)
- Hearth disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dr.K. TreatmentOverweight and obesity treatment response | Combination product | LC, NLC |
Primary outcome
Change in body composition with a scientific impedanciometer
Time frame: Baseline and weeks: 1, 4, 8, 12,16
Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)
1 secondary outcome
Change in perimeters measured with measuring tape
Time frame: Baseline and weeks: 1, 4, 8, 12,16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Results publication: PubMed 26082579Byun 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.
- Results publication: PubMed 21284660Escudier 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.
- Results publication: PubMed 17441853Salavert 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.
- Individual participant dataSharing planned: Yes. Anonymous patient information will be shared only if requested and justified in writing by researchers. It will be evaluated in committee if it is a justified request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dr.K. Treatment in people with Lipolysis and Overweight and Obesity, run by BiomediKcal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition with a scientific impedanciometer (time frame: Baseline and weeks: 1, 4, 8, 12,16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721185, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.