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 |
- 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
| Study design | Prospective multicenter 8-week parallel-group randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Medical and other records |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 1. The percentage of subjects who achieved an improvement of at least one point in the hyperpigmentation score from baseline to week 8 2. Glogau score and a clinical score that assessed four parameters (wrinkles, elasticity, skin uniformity, and hyperpigmentation) with a 4-point score for each item (ranging from 0 = no issue to 3 = severe issue) from baseline to week 8 |
| Secondary outcome measures | 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 2. VISIA® objective face sculptor analysis performed in a subgroup of 10 subjects from baseline to week 8 |
| Overall study start date | 01/02/2025 |
| 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 number of participants | Group A: 47, Group B: 44 |
| 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
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39 (0)3802607820 |
|---|---|
| stefano.alfano@difacooper.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 06/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication in a peer-reviewed journal |
| 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 |
Editorial Notes
28/07/2025: Study's existence confirmed by Medizioni S.r.l.
