NCT07040345: EAAO22G01

Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation

Completed NA Last updated 27 June 2025

What this trial tests

NA trial testing Annurca apple oleolite in Hyperpigmentation in 48 participants. Completed in 20 December 2022.

Timeline

1 February 2022

Primary endpoint
30 April 2022

20 December 2022

Quick facts

Lead sponsor	Ritamaria Di Lorenzo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	48
Start date	1 February 2022
Primary completion	30 April 2022
Estimated completion	20 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Annurca apple oleolite
• Placebo

Conditions studied

• Hyperpigmentation — all drugs for Hyperpigmentation →
• Melasma — all drugs for Melasma →
• Skin Spots — all drugs for Skin Spots →
• Photodamaged Skin — all drugs for Photodamaged Skin →

Sponsor

Ritamaria Di Lorenzo

Who can join

Adults 40 to 65, female only, with Hyperpigmentation or Melasma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this cosmetic clinical trial is to learn if an oleolite derived from Annurca Apple peel (AAO) works to enhance skin tone and luminosity, by counteracting the visibility of skin hyperpigmentation and dark spots in adult women with photo-damage. It will also learn about the safety and tolerability of the cosmetic active ingredient. The main questions it aims to answer are:

Does cosmetic active ingredient improve skin tone, luminosity and reduce skin spots visibility? What skin benefits do participants have when using this new active ingredient in a cosmetic formulation? Researchers will compare the AAO to a placebo (a look-alike cosmetic formulation that contains no AAO) to see if AAO works as a depigmenting and whitening ingredient for skin wellness.

Participants will:

Take AAO or a placebo every day twice daily for 28 days (4 weeks) Visit the clinic once every 2 weeks for check-ups and skin parameters observation Keep a diary of the potential adverse reactions that might result from using the assigned test products

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Apple oil as a source of ursolic acid for the treatment of hyperpigmentary disorders with molecular and clinical evaluation.
   Maisto M, Piccolo V, Marzocchi A, Ricci L, et al · · 2025 · PMID 41387498 · DOI 10.1038/s41598-025-29398-0