HyperpigmentationEAAO22G01NCT07040345
Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation
A study testing Annurca apple oleolite in people with Hyperpigmentation and Melasma, run by Ritamaria Di Lorenzo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Melasma, Skin Spots
- What is being tested?
- Annurca apple oleolite
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Evaluation of Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation
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.
Read more
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
Read the 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
- Being tested
- Annurca apple oleolite, Placebo
- Keywords
- hyperpigmentation, melanogenesis, melasma, skin spots, photodamage
- Medical subject headings
- Hyperpigmentation, Melanosis, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annurca apple oleoliteOther
3 mg twice daily for 28 days
PlaceboOther
3 mg twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| AAO | Active comparator | Annurca apple oleolite at 2.5% w/w in a cosmetic w/o emulsion twice per day for 28 days Receives: Other: Annurca apple oleolite |
| Placebo | Placebo comparator | cosmetic w/o emulsion without the active comparator twice daily for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depigmenting activity
- 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ritamaria Di Lorenzo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ritamaria Di Lorenzo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040345
- Sponsor's protocol ID
- EAAO22G01
- Other IDs
- EAAO22G01
- Acronym
- EAAO22G01
- Status last verified
- Jan 2023
- First submitted
- 5 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation
- ClinicalTrials.gov ID
- NCT07040345
- Acronym / sponsor ID
- EAAO22G01 / EAAO22G01
- Conditions
- Hyperpigmentation, Melasma, Skin Spots, Photodamaged Skin
- Keywords
- hyperpigmentation, melanogenesis, melasma, skin spots, photodamage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ritamaria Di LorenzoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAO | Active comparator | Other: Annurca apple oleoliteAnnurca apple oleolite at 2.5% w/w in a cosmetic w/o emulsion twice per day for 28 days |
| Placebo | Placebo comparator | Other: Placebocosmetic w/o emulsion without the active comparator twice daily for 28 days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy Caucasian subjects
- Age: 18 - 70 years
- Sex: feminine
- Normal adult skin, with spots extinct and wrinkles
- Sensitive skin, with brown spots
Key exclusion criteria (13 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annurca apple oleolite3 mg twice daily for 28 days | Other | AAO |
| Placebo3 mg twice daily for 28 days | Other | Placebo |
Primary outcome
Depigmenting activity
Time frame: 28 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annurca apple oleolite in people with Hyperpigmentation and Melasma, run by Ritamaria Di Lorenzo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depigmenting activity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.