Evaluation of the injectable medical device Hydragel A2 for skin quality improvement
| ISRCTN | ISRCTN37981524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37981524 |
| Secondary identifying numbers | 2223CMPH145 |
- Submission date
- 12/10/2023
- Registration date
- 17/10/2023
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Hydragel A2 is classified as a medical device and its intended purpose is to improve skin quality attributes such as skin elasticity and skin hydration, and to correct mild skin depression. Hydragel A2 is intended to be used by healthcare professionals in accordance with local regulations for this kind of treatment. The aim of this study is to evaluate the safety and effectiveness of Hydragel A2 in the improvement of skin quality at 2 and 6 weeks post injection.
Who can participate?
Healthy adults aged between 30 to 60 years old seeking an improvement in the skin of the face
What does the study involve?
The study duration is 4 months. Participants will undergo a visit for screening followed by measurements of skin density, thickness, elasticity, hydration and brightness. The injection of Hydragel A2 will be performed on both cheeks and a subjective evaluation will be carried out by the injector.
What are the possible benefits and risks of participating?
Hydragel A2 fillers have been widely used for facial rejuvenation for the past 20 years. Most treated subjects reported that they would recommend Hydragel A2 dermal fillers to their peers for facial rejuvenation.
The anticipated clinical benefits are the aesthetic improvement of facial skin quality and skin radiance in treated subjects. Skin quality improvement is defined as improvement of skin elasticity and firmness.
Injection with a Hydragel A2 device is less invasive and less permanent compared to surgical methods such as facial lifting or autologous fat transfer.
The following risks and expected adverse events are foreseen with Hydragel A2 devices:
Events which are naturally resolved within 1 week in most cases:
1. Injection-related events and/or inflammatory reactions such as bleeding, ecchymosis, erythema, haematoma, skin redness, bruising, swelling, oedema and infection which may be associated with local pain or itching, occurring after injection.
2. Sensitivity at the injection site.
3. Hardness, lump or nodule at the injection site.
4. Skin coloration or discoloration at the injection site.
Events which will have delayed resolution after the injection:
1. Immediate or delayed hypersensitivity to hyaluronic acid and/or to tranexamic acid.
2. Infection or reactivation of a previous infection.
3. Displacement of the gel.
Inflammatory reactions which persist for more than one week, or any other adverse event which develops, must be reported to the investigator. In this case, if required, the investigator can use an appropriate treatment.
Where is the study run from?
Louna Aesthetics (France)
When is the study starting and how long is it expected to run for?
June 2023 to August 2024
Who is funding the study?
Louna Aesthetics (France)
Who is the main contact?
Dr Ounisha Mungur, o.mungur@cidp-cro.com
Contact information
Public, Scientific, Principal Investigator
BioPark Mauritius, SOCOTA Phoenicia
Sayed Hossen Road
Phoenix
73408
Mauritius
| Phone | +230 (0)58566989 |
|---|---|
| o.mungur@cidp-cro.com |
Study information
| Study design | Prospective open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Safety and effectiveness clinical evaluation of injectable medical device hydragel A2 in the improvement of skin quality |
| Study objectives | The null hypothesis states that less than 40% of subjects are responders with global aesthetic improvement (GAIS). It is assumed that under the alternative hypothesis 65% of subjects are responders. Using a two-sided exact one-sample binomial test, 40 subjects are required to show with a power of 90% a significant result (alpha = 5%). |
| Ethics approval(s) |
Approved 17/01/2024, Clinical Research Regulatory Council (Atchia Building, Suffren Street, Port-Louis, 11405, Mauritius; +230 (0)59439503; crrc@govmu.org), ref: 2223CMPH145 |
| Health condition(s) or problem(s) studied | Face skin quality |
| Intervention | This study will be conducted as a prospective and open study to evaluate the effectiveness of the Medical Device on the improvement of skin quality by objective measurements of skin quality at 2 weeks and 6 weeks post-injection. Participants will undergo a visit at D-30 for screening followed by a visit at D-3-D0 whereby several parameters will be measured for skin density, thickness, elasticity, and hydration. At the baseline visit (D0), HYDRAGEL A2 will be injected on both cheeks and a subjective evaluation will be done by the injector. After 2 weeks (visit W2) and 6 weeks (visit W6), skin parameters will be measured for density, thickness, elasticity, and hydration. Device classification HYDRAGEL A2 is classified as a class III (rule 7, Chapter III of the Regulation (EU) 2017/745 and rule 18) medical device. Description of the investigational device HYDRAGEL A2 device is a sterile, translucent and resorbing gel of hyaluronic acid of biofermentative origin. Polynucleotide in the form of PDRN a substance widely used in the cosmetic industry, is incorporated to the gel to protect the HA molecules against free radicals. The content of HYDRAGEL A2 vial is sterilised by moist heat. HYDRAGEL A2 has the following properties: 1. Injectable resorbable gel (non-permanent gel) 2. Sterile and single use 3. Packaged in a 6 ml glass vial, in a volume of 3.0 ml 4. Presented in a secondary packaging that protects the integrity of each vial 5. Stored either in ambient (2 to 25°C) conditions for 36 months The raw materials and components which compose HYDRAGEL A2 products are compliant with the European Pharmacopoeia when monographs exist and/or applicable normative standards. The production of HYDRAGEL A2 is subcontracted to a contract manufacturer which is specialised in the manufacturing of medical devices and pharmaceutical products. Each box (secondary packaging) of HYDRAGEL A2 device contains three pre-filled vials of HYDRAGEL A2 and a set of implant cards. The composition is below: HYDRAGEL A2 1. Hyaluronic acid: 5 mg/ml 2. Polynucleotide: 7.5 mg/ml 3. Phosphate buffer and niacinamide q.s. 1 ml |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hydragel A2 |
| Primary outcome measure | The effectiveness of “HYDRAGEL A2” assessed using clinical evaluation of the global aesthetic improvement (GAIS) rated by the investigator at 2 weeks (W2) after the injection |
| Secondary outcome measures | 1. Skin quality assessed by objective measurements of skin texture (roughness) at 2 and 6 weeks post-injection with Antera 3D 2. Skin quality assessed by objective measurements of: 2.1. Skin firmness/elasticity by Cutometer® 2.2. Skin hydration by Corneometer® 2.3. Skin density and thickness using Dermascan at 2 and 6 weeks after injection 3. Proportion of subjects having an improvement of the zone treated with the overall VISCOL range of devices as assessed by an independent investigator using the GAIS at 6 weeks (W6) after treatment 4. The satisfaction of the injector on the injection quality assessed using a subjective evaluation questionnaire at Day 0 5. The treatment effect of the product assessed using 2D photography at Week 2 and Week 6 6. The safety of the HYDRAGEL A2 through the incidence of signs and symptoms of skin irritation or sensitivity (using the Injection Site Reaction questionnaire) during the entire period of the study 7. The subject’s satisfaction with global aesthetic improvement (GAIS) at 2 weeks and 6 weeks after the injection 8. The effectiveness of HYDRAGEL A2 assessed using clinical evaluation of the GAIS rated by the investigator at 2 weeks and 6 weeks after the injection 9. Patient satisfaction with the treatment outcomes using a subjective evaluation questionnaire completed at 2 weeks (W2) and 6 weeks (W6) after treatment |
| Overall study start date | 20/06/2023 |
| Completion date | 16/08/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 49 |
| Key inclusion criteria | Current inclusion criteria as of 12/02/2024: 1. Female or male 2. Any ethnicity 3. Skin phototype (according to Fitzpatrick scale) from II to V 4. Aged 30 to 60 years old 5. Seeking improvement of their skin quality 6. Have given consent for photographs for illustration purposes 7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration 8. In good general and mental health in the opinion of the investigator 9. Have the ability to read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent 10. Agreeing to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to protocol 11. In the judgement of the investigator, are likely to be compliant during the study 12. Willing and capable of following the study rules and a fixed schedule 13. Willing and capable of signing an informed consent document (including the language) _____ Previous inclusion criteria: 1. Female or male 2. Any ethnicity 3. Skin phototype (according to Fitzpatrick scale) from II to V 4. Aged 18 to 45 years old 5. Seeking improvement of their skin quality 6. Have given consent for photographs for illustration purposes 7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration 8. In good general and mental health in the opinion of the investigator 9. Have the ability to read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent 10. Agreeing to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to protocol 11. In the judgement of the investigator, are likely to be compliant during the study 12. Willing and capable of following the study rules and a fixed schedule 13. Willing and capable of signing an informed consent document (including the language) |
| Key exclusion criteria | 1. Any systemic disorder or skin disease that would in any way confound the interpretation of the study results 2. Medical/surgical/severe allergy/anaphylactic shock history that, in the opinion of the Investigator, could compromise the safety of the participant or affect the outcome of the study 3. Known risk of hypersensitivity to one of the components of the IP composition 4. Suffering from autoimmune disease 5. Cutaneous disorders, inflammation or infection (herpes, acne, etc.) at the treatment site or nearby 6. Medical history shows a sensitivity that could lead to a reaction to the treatment 7. Bleeding disorders or undergoing treatment with thrombolytics or anticoagulants 8. A tendency to form keloids, hypertrophic scars or any other healing disorders 9. Currently following a skin treatment 10. Pregnant or breastfeeding women or those considering a pregnancy during the study 11. Female subjects of childbearing potential with a positive urine pregnancy test (UPT) at D-3-D0 12. Deprived of their freedom by administrative or legal decision or who is under guardianship 13. Cannot be contacted by telephone in case of emergency 14. In an exclusion period or participating in another biomedical research study (self-reported) 15. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation |
| Date of first enrolment | 28/05/2024 |
| Date of final enrolment | 01/07/2024 |
Locations
Countries of recruitment
- Mauritius
Study participating centre
Sayed Hossen Road
Phoenix
73408
Mauritius
Sponsor information
Industry
30 route des Creusettes
Poisy
74330
France
| Phone | +33 (0)6 02511769 |
|---|---|
| contact@louna-aesthetics.com | |
| Website | https://www.innovyal.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 04/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
09/07/2024: The overall end date was changed from 04/08/2024 to 16/08/2024.
04/06/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 15/04/2024 to 28/05/2024.
2. The recruitment end date was changed from 23/05/2024 to 01/07/2024.
12/02/2024: The following changes were made to the trial record:
1. The overall end date was changed from 22/04/2024 to 04/08/2024.
2. The inclusion criteria were changed.
3. The recruitment start date was changed from 28/11/2023 to 15/04/2024.
4. The recruitment end date was changed from 28/01/2024 to 23/05/2024.
5. The plain English summary was updated to reflect these changes.
6. The intention to publish date was changed from 22/04/2025 to 04/08/2025.
16/10/2023: Study's existence confirmed by the Clinical Research Regulatory Council Mauritius.
