Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation

NCT ID: NCT07040345

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-20

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

Detailed Description

The skin effects of the AAO were evaluated through a monocentric, double-blind, placebo-controlled, parallel-arm, randomized clinical study. Healthy Italian subjects (age 40-65; n=48) were enrolled in this 4-week study. Before participating, each subject signed a written informed consent that contained the aim and the type of the study, the list of the cosmetic-grade ingredient employed fort the preparation of the cosmetic formulation, the rules to be followed, and any known or potential adverse reactions that might result from using the test products.

All subjects were selected based on the presence of photodamage and hyperpigmentation. Enrolled subjects underwent to 30-day washout period, in which they were instructed to stop using their usual cosmetic products, whereas they were permitted to continue their normal facial treatment regimen (e.g., facial cleanser, make-up and make-up removal) that did not contain ingredients with lightening or whitening action. Once the wash-out period elapsed, subjects were supplied with test products (placebo and the same formulation added with AAO).

Panelists had to apply the assigned emulsion twice daily (morning and evening) for 4 weeks. The application amount had to be approximately 0.3 g of product (two pumps) on a dry or slightly moistened face. Massage in, avoiding direct contact with the eyes. Upon application, in case of individual hypersensitivity, discontinue treatment. Do not use on irritated or chapped skin. For the evening application wait for at least 1 h before bedtime.

Digital images of all subjects were captured at baseline and at weeks 2 and 4, with VISIA® 7th (Canfield Scientific Inc., Parsippany, NJ 07054 USA). The skin imaging system exploits RGB technology to record and measure UV and brown spots, and skin tone. Before image capture, subjects were equilibrated in a controlled temperature room (22 ± 2 °C) for 30 minutes. The hair of the participants was tied up and their clothing was covered with black cloth. The images were taken by the same operator using the same imaging equipment under the same conditions (lighting, distance, head position, etc.) at all time points. Accurate subjects' repositioning was obtained by comparing the live image with the ghost-baseline digitally stored photo. Computer analysis of the digital images allowed quantification of the hyperpigmentation and dark spots.

Facial skin color and spots were also detected through reflectance and spectro-photometric skin devices, like Skin-Colorimeter® CL 400 and Mexameter® MX 18 (Courage+Khazaka electronic GmbH). Specifically, the skin luminosity, melanin index and skin complexion were monitored during the trial.

Conditions

Hyperpigmentation; Melasma; Skin Spots; Photodamaged Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

AAO

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

Group Type: ACTIVE_COMPARATOR

Annurca apple oleolite

Intervention Type: OTHER

3 mg twice daily for 28 days

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

3 mg twice daily for 28 days

Interventions

Annurca apple oleolite

3 mg twice daily for 28 days

Intervention Type: OTHER

Placebo

3 mg twice daily for 28 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• - 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ritamaria Di Lorenzo

OTHER

Sponsor Role: lead

Responsible Party

Ritamaria Di Lorenzo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Naples Federico II, Napoli, Italy 80131

Napoli, , Italy

Countries

Italy

Other Identifiers

EAAO22G01

Identifier Type: OTHER

Identifier Source: secondary_id

EAAO22G01

Identifier Type: -

Identifier Source: org_study_id