Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation (NCT07040345) | Clinical Trial Compass
CompletedNot Applicable
Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation
Italy48 participantsStarted 2022-02-01
Plain-language 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
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disord…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.