Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation

NCT07040345 | Completed DMC

• 1 other identifier: EAAO22G01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperpigmentation; Melasma; Skin Spots; Photodamaged Skin

Keywords

hyperpigmentation; melanogenesis; melasma; skin spots; photodamage

Outcome Measures

Primary Outcomes (1)

• Depigmenting activity

  i) skin tone with Individual Typology Angle (ITA°) ii) hyperpigmentation through Melanin index (A.U.) iii) UV and Brown spots (score) were monitored using Mexameter MX18 after 14 and 28 days of treatment.

  28 days

Study Arms (2)

AAO

ACTIVE COMPARATOR

Annurca apple oleolite at 2.5% w/w in a cosmetic w/o emulsion twice per day for 28 days

Other: Annurca apple oleolite

Placebo

PLACEBO COMPARATOR

cosmetic w/o emulsion without the active comparator twice daily for 28 days

Other: Placebo

Interventions

Annurca apple oleolite OTHER

3 mg twice daily for 28 days

AAO

Placebo OTHER

3 mg twice daily for 28 days

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Caucasian subjects
• Age: 18 - 70 years
• Sex: feminine
• Normal adult skin, with spots extinct and wrinkles
• Sensitive skin, with brown spots
• Phototype: II - III Fitzpatrick scale
• Subjects who have read and signed the informed consent written by the investigators
• Subjects who did not apply on the test area other products than the one studied and no product within seven days before the test
• Subjects who have agreed to follow the study rules and the planned check-ups
• Subjects who have agreed not to expose themselves to UV for the study duration

You may not qualify if:

• \- Pregnant or breastfeeding women
• Subjects with anamnesis of cutaneous hyper-reactivity or intolerance reactions to cosmetic products/ingredients
• Subjects with diseases in the period immediately preceding the current study
• Subjects undergoing topical or systemic treatment with any drug that may affect the outcome of the test or affected by skin diseases (eczema, psoriasis, lesions)
• Subjects receiving topical or oral retinoic acid or any derivative of vitamin A (tretinoin or isotretinoin) in the six months before the start of the study and systemically in the previous 12 months
• Subjects who performed treatments with topical products based on alpha and beta-hydroxy acids, or other whitening agents, the 45 days before the test start
• Subjects who took systemic antiaging and antioxidant supplements within 60 days before the start of the study
• With thyroid disorders (hyperthyroidism/hypothyroidism) and who are not undertaking due treatment, or those taking the medications for less than one year
• Who has received a facial filling in the last 12 months
• Who is doing any facial aesthetic procedure
• Who are using cosmetics or medications that may increase the photosensitivity of the skin
• Who have undergone bariatric surgery or who are confined to a strict diet
• Who is using any supplement (topic or oral) for the improvement of their skin condition

Sponsors & Collaborators

• Ritamaria Di Lorenzo: lead

Study Sites (1)

University of Naples Federico II, Napoli, Italy 80131

Napoli, Italy

Location

MeSH Terms

Conditions

Hyperpigmentation; Melanosis; Exanthema

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 27, 2025
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: December 20, 2022
• Last Updated: June 27, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)