A study to assess the safety and efficacy of poly-L-lactic acid dermal filler in the enhancement of buttocks and treatment of cellulite
| ISRCTN | ISRCTN14093985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14093985 |
| Secondary identifying numbers | CS-21-05 |
- Submission date
- 12/03/2025
- Registration date
- 12/03/2025
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The purpose of the clinical investigation is to assess the safety and effectiveness of poly-L-lactic acid dermal fillers in buttock augmentation and the treatment of buttock/thigh cellulite. Poly-L-lactic acid dermal fillers are designed to restore skin volume and improve skin texture and are used to reshape contours and reduce flaccidity.
Who can participate?
Men and women aged between 25 and 50 years old
What does the study involve?
Participants receive poly-L-lactic acid injections. The study consists of a screening visit which can take place up to 14 days before treatment on Day 0 or alternatively, the screening visit and baseline treatment can both take place on day 0. Treatment will also be performed at the month 2 visit and an optional third treatment at month 4. There will be six visits to assess effectiveness and safety at months 2, 4, 6, 12, 18, and 25. A safety check of participant diaries is performed in week 2.
What are the possible benefits and risks of participating?
There are risks related to the administration procedure per se (irrespective of the filler), including but not limited to bruising, swelling, redness, and infection. On rare occasions participants may experience hypersensitivity to Lanluma X. The study will help to accumulate data on the long-term safety and effectiveness of Lanluma X.
Where is the study run from?
1. Dr. Kai O. Kaye (Spain)
2. Dr. Pilar de Frutos (Spain)
When is the study starting and how long is it expected to run for?
October 2021 to November 2025
Who is funding the study?
Sinclair Ltd (UK)
Who is the main contact?
Dr Stuart Boothman, sboothman@sinclair.com
Contact information
Scientific
Sinclair Pharmaceuticals Ltd
Eden House
Lakeside
Chester Business Park
Chester
CH4 9QT
United Kingdom
| Phone | +44 (0)1244 625127 |
|---|---|
| sboothman@sinclair.com |
Principal Investigator
Av. Ramón y Cajal 7
Marbella
29601
Spain
| Phone | +34 (0)951775518 |
|---|---|
| dr.kaye@oceanclinic.net |
Public
RQM+ (Germany) GmbH
von-Geismar-Strasse 2
Ahlen
59229
Germany
| Phone | +49 (0)1702062568 |
|---|---|
| smletzko@rqmplus.com |
Study information
| Study design | Multicentre prospective open-label (non-randomized) interventional post-market clinical follow-up (PMCF) study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other therapist office |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | A post-market follow-up study to assess the safety and efficacy of Lanluma X in the enhancement of buttocks and treatment of cellulite |
| Study objectives | The primary hypothesis is that the efficacy of Lanluma X will be evident at 6 months post-treatment, while the secondary hypothesis is that Lanluma X will be efficacious and safe over the entire study period. |
| Ethics approval(s) |
Approved 15/12/2022, Consejería De Salud Y Consumo (Avenida De La Innovación, Edificio Arena 1, Sevilla, 41020, Spain; +34 (0)955 00 63 00; consejera.csc@juntadeandalucia.es), ref: 202599900769088 |
| Health condition(s) or problem(s) studied | Enhancement of the volume of the buttocks and correction of skin depressions such as cellulite |
| Intervention | Poly-L-lactic acid dermal filler (Lanluma X) is a CE-marked medical device and is injected at baseline and 2 months (following assessment of efficacy and safety). There is an optional retreatment of Lanluma X at 4 months. There are seven follow-up visits to assess efficacy and safety: at week 2 (only safety), month 2 (prior to the second treatment), month 4 (prior to optional third treatment), months 6, 12, 18, and 25. At these visits, the effect of the treatment will be assessed and documented using live GAIS evaluations, and standardised photography. Satisfaction questionnaires for subjects and study physicians are an integral part of this aesthetic study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Poly-L-lactic acid |
| Primary outcome measure | The proportion of participants (%) with an improvement (i.e., improved, much improved or very much improved) over baseline at 6 months in Global Aesthetic Improvement Scale (GAIS) assessments of buttocks augmentation and/or cellulite appearance in buttocks/thighs, as assessed by an on-site independent evaluator |
| Secondary outcome measures | 1. The proportion of participants (%) with an improvement (i.e., improved, much improved or very much improved) over baseline at 6 months in Global Aesthetic Improvement Scale (GAIS) assessments of buttocks augmentation and/or cellulite appearance in buttocks/thighs at 2, 4, 12, 18 and 25 months, as assessed by an on-site independent evaluator and self-assessed by participants 2. The proportion of participants (%) exhibiting a reduction of ≥1 point from baseline in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for cellulite appearance in buttocks and/or thighs at 2, 4, 6, 12, 18 and 25 months as assessed by a blinded remote independent evaluator 3. Participant and Investigator treatment satisfaction based on questionnaires completed by the participants (at 2, 4, 6, 12, 18 and 25 months post-treatment) and the investigators (after treatment) |
| Overall study start date | 01/10/2021 |
| Completion date | 15/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 73 |
| Key inclusion criteria | 1. Subjects who: 1.1 Are seeking buttock augmentation And/or 1.2. Are seeking treatment for reduction of mild to moderate (2-3) cellulite in the region of the buttocks and/or the back of the thighs when assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2. Female and male subjects aged 25-50 years of age 3. Body mass index ≤30 kg/m² 4. Subjects who are willing to provide written informed consent including approval of the use of their data and photographs in this study and any subsequent publications or presentations 5. Subjects willing to commit to having no further aesthetic treatments in the buttocks and thighs, such as body contouring procedures, for the duration of the study period 6. Subjects willing to commit to having no further tattoos on the buttocks and thighs for the duration of the study period 7. Females of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the entire study |
| Key exclusion criteria | 1. Subjects meeting any of the following criteria will be excluded from the study: subjects who, in the months prior to their enrollment assessment, have undergone any of the following treatments in the buttocks and thighs: 3 months prior: - Mesotherapy - Resurfacing (e.g., laser, radio frequency, dermabrasion, or chemical peel) 6 months prior: - Temporary filler (e.g., Ha, CaHA, PCL) - Neuromodulator injections 12 months prior: - Cosmetic plastic surgery in the area to be treated - Tissue grafting (e.g., fat injections) - Tissue lifting implants (e.g., threads, barbs) or other implants - Augmentation with semi-permanent filler (e.g., PLLA) 2. Previous augmentation with any permanent filler in the region of the buttocks or thighs 3. Subjects who have received any other aesthetic procedures in the region of the buttocks or thighs at any time during the study period 4. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship 5. Subject is an employee of the aesthetic surgery department on the investigational site, the Contract Research Organisation (CRO) or study sponsor 6. Subjects who in the opinion of the investigator are unsuitable to take part in the study for scientific or medical reasons 7. Subjects currently enrolled in other clinical trials 8. Excessive subcutaneous fat in the region of the buttocks and thighs 9. Excessive skin laxity in the region of the buttocks and thighs 10. Subjects who, if female, are pregnant or plan to become pregnant during the study period 11. Subjects with known allergies to the product ingredients (i.e. Poly-L-lactic Acid (PLLA), sodium carboxymethyl cellulose (CMC), Mannitol) 12. Subjects must avoid receiving a Coronavirus Disease (COVID) -19 vaccination for the 14 days before and following the injection. 13. Subjects with a cutaneous disorder, inflammation, infection, significant scarring, open wounds, lesions or tattoos in the region of the buttocks and thighs 14. Subjects taking thrombolytics or anticoagulants 15. Subjects with bleeding disorders 16. Subjects with a history of severe allergy or anaphylactic shock 17. Subjects with active (or a history of) autoimmune disease 18. Subjects with porphyria 19. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders |
| Date of first enrolment | 13/01/2023 |
| Date of final enrolment | 08/05/2023 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29601
Spain
Madrid
28010
Spain
Sponsor information
Industry
Eden House Lakeside
Chester Business Park
Chester
CH4 9QT
England
United Kingdom
| Phone | +44 (0)1244 625127 |
|---|---|
| sboothman@sinclair.com | |
| Website | https://sinclair.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | There are no plans to make available the raw data to the scientific community. |
Editorial Notes
12/03/2025: Study's existence confirmed by Comité de Ética de la Investigación Provincial de Málaga.
