Clinical and instrumental study on the anti-ageing effects of creams with hyaluronic acid, with and without Vitamin C
| ISRCTN | ISRCTN85920423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85920423 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Cantabria Labs Difacooper |
| Funder | Cantabria Labs Difa Cooper |
- Submission date
- 25/07/2025
- Registration date
- 28/07/2025
- Last edited
- 28/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aim
Skin ageing is a multifaceted process influenced by both intrinsic and extrinsic factors, resulting in visible changes such as wrinkles, loss of elasticity, uneven skin tone, and hyperpigmentation. Hyaluronic acid (HA) is widely recognized for its hydrating and structural support properties, while Vitamin C is known for its antioxidant and depigmenting effects. This study investigated the anti-ageing effect of two topical formulations containing Jalubalance® technology - HA delivered in Opuntia oil, with or without 1% Vitamin C.
Who can participate?
Women aged between 30 and 50 years with mild to moderate photoaging
What does the study involve?
Participants were assigned to apply either HA-only cream (Group A) or a HA + Vitamin C cream (Group B) twice daily. The primary outcome was the percentage of subjects who achieved an improvement of at least one point in the hyperpigmentation score from baseline to week 8. Additionally, the study aimed to evaluate and compare the effects of both treatments, with a particular focus on improvements in wrinkles, elasticity, hydration, and pigmentation.
What are the possible benefits and risks of participating?
Benefits: improvement in skin ageing parameters. There are no expected risks for the participants.
Where is the study run from?
Donne Dermatologhe Italia (Italy)
When is the study starting and how long is it expected to run for?
February 2025 to June 2025
Who is funding the study?
Cantabria Labs Difa Cooper (Italy)
Who is the main contact?
Dr Massimo Milani, massimo.milani@difacooper.com
Contact information
Public, Scientific, Principal investigator
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39 (0)3802607820 |
|---|---|
| stefano.alfano@difacooper.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective multicenter 8-week parallel-group randomized study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical and instrumental evaluation of the anti-ageing effectiveness of a cream based on hyaluronic acid and a cream based on hyaluronic acid and Vitamin C: a prospective, multicenter, 8-week, parallel-group randomized study on 91 subjects |
| Study objectives | The addition of 1% Vitamin C in a face cream improves skin quality parameters |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Skin aging |
| Intervention | Patients were randomized in a 1:1 ratio and instructed to apply a cream formulated with red algae and Lactobacillus, enriched with Jalubalance® technology (high-concentration hyaluronic acid delivered through Opuntia oil) (HA-only cream, Group A), or to apply a cream that combines the Jalubalance® technology with 1% Vitamin C (HA-Vitamin C cream, Group B). The products were applied to the entire face twice daily (morning and evening) for 8 weeks, using 1.5 g of product per application (3 FTUs) on cleansed skin. A dedicated computer program was used to generate the randomization list. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The percentage of subjects who achieved an improvement of at least one point in the hyperpigmentation score from baseline to week 8 |
| Key secondary outcome measure(s) |
1. Instrumental evaluation of treatment efficacy using the Digital Skin Moisture Meter, which measures skin hydration, sebum content, and skin elasticity, from baseline to week 8 |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 91 |
| Total final enrolment | 91 |
| Key inclusion criteria | 1. Women with mild to moderate photoaging (Glogau score 1 or 2) 2. Age between 30 and 50 years |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Allergy to components present in the products 3. Acute facial skin diseases |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 01/04/2025 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milan
20121
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the privacy of the patients involved |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/07/2025: Study's existence confirmed by Medizioni S.r.l.
