A high-protection sunscreen with natural ingredients helps reduce dark patches and signs of skin aging on the face

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18053239

Enrollment

Registered

2025-10-27

Start date

2023-02-20

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The use of a sunscreen 50+ containing polypodium leucotomos extract, ellagic acid and niacinamide in patients with melasma Skin and Connective Tissue Diseases

Interventions

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 follo

Eligibility

Sex/Gender

Female

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Caucasian women aged 25 to 60 years 2. Facial melasma present for at least 5 months

Exclusion criteria

Exclusion criteria: 1. Presence of other facial disorders 2. Use of topical treatments within the two months preceding study initiation 3. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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) 2. Cytological characteristics relevant to melasma diagnosis and classification 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)	—

Measure

Time frame

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) 2. Cytological characteristics relevant to melasma diagnosis and classification 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)

—

Countries

Italy

Contacts

Public ContactMassimo Milani

massimo.milani@difacooper.com+39 29659031

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026