A high-protection sunscreen with natural ingredients helps reduce dark patches and signs of skin aging on the face
| ISRCTN | ISRCTN18053239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18053239 |
| 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
- 24/10/2025
- Registration date
- 27/10/2025
- Last edited
- 24/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Melasma is a common skin condition that causes dark patches on the face, especially in areas exposed to the sun. It’s more noticeable in people with lighter skin and can be triggered or worsened by sunlight. Many current treatments can cause irritation, take a long time to work, or lead to the skin lightening too much, especially in people with darker skin. This study looked at whether a special sunscreen containing ellagic acid, niacinamide, and a plant extract called Polypodium Leucotomos could help improve melasma without these side effects.
Who can participate?
The study included Caucasian women aged 25 to 60 years who had melasma on their face for at least five months.
What does the study involve?
Participants used a fluid cream sunscreen with added ingredients thought to help with melasma. The study tracked how their skin responded over time, but there was no comparison group or placebo.
What are the possible benefits and risks of participating?
Using the sunscreen may help reduce melasma and prevent it from coming back, without causing harm or side effects.
Where is the study run from?
Cantabria Labs Difa Cooper (Italy)
When is the study starting and how long is it expected to run for?
January 2023 to July 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
Via Milano, 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39 29659031 |
| massimo.milani@difacooper.com |
Principal investigator
Via Sergio Pansini, 5
Napoli
80131
Italy
| Phone | +39 817463762 |
|---|---|
| alessia.villani@unina.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot prospective open-label study with a total duration of three months followed by a three-month follow-up |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A 50+ sunscreen containing polypodium leucotomos extract, ellagic acid, and niacinamide reduces facial melasma and photoaging-related hyperpigmentation: a pilot clinical and confocal microscopy evaluation |
| Study acronym | PIGMENT |
| Study objectives | The study aimed to evaluate the efficacy of a fluid emulsion with SPF 50+ containing ellagic acid, niacinamide, Fernblock®+ (Polypodium Leucotomos extract), and vitamin E in the prevention and treatment of melasma and photoaging, using in vivo confocal microscopy |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | The use of a sunscreen 50+ containing polypodium leucotomos extract, ellagic acid and niacinamide in patients with melasma |
| Intervention | Patients were instructed to apply the product every morning and reapply it every two hours during sun exposure, for a period of 12 weeks. The study lasted three months, followed by a three-month follow-up phase. Participants attended three study visits: at baseline (T0), after 12 weeks of treatment (T1), and after 24 weeks for the follow-up evaluation (T2). |
| Intervention type | Other |
| Primary outcome measure(s) |
Evaluation of clinical efficacy through the Melasma Area Severity Index (MASI) at baseline (T0), after 12 weeks of treatment (T1), and after 24 weeks for the follow-up evaluation (T2). The MASI was calculated by evaluating three factors: area involved (A), darkness (D), and homogeneity (H), across four distinct regions: the forehead, right malar region, left malar region, and chin. The total score range is 0 to 48. |
| Key secondary outcome measure(s) |
1. Abnormal pigment deposits are measured using in vivo confocal microscopy (CM) at baseline (T0), after 12 weeks of treatment (T1), and after 24 weeks for follow-up evaluation (T2) |
| Completion date | 01/07/2025 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 60 Years |
| Sex | Female |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Caucasian women aged 25 to 60 years 2. Facial melasma present for at least 5 months |
| Key exclusion criteria | 1. Presence of other facial disorders 2. Use of topical treatments within the two months preceding study initiation 3. Pregnancy or lactation |
| Date of first enrolment | 20/02/2023 |
| Date of final enrolment | 07/12/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Napoli
80131
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Massimo Milani (massimo.milani@difacooper.com) |
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
24/10/2025: Trial's existence confirmed by Medizioni SRL.
