Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT05972434
Eligibility Criteria:
Inclusion Criteria:
* Participants of any ethnicity according to IBGE criteria
* Generally in good health based on medical history reported by the participant
* Able to read, write, speak, and understand Portuguese
* Capacity to consent to participation in the study
* Fitzpatrick Skin Type I to IV
* Intact skin in the test region
* Specific for Group 1: Participants with dry skin on the forearms (Corneometer score of maximum 40 arbitrary units (a.u.) at initial measurement before application of the products
* Participants with a maximum facial corneometry value of 60 a.u. at the initial measurement before the application of the products
* Participants presenting recent and repetitive complaints of discomfort caused by dry skin on the face, such as: pining, itching, irritation, et cetra
* Specific for Group 2: Participants who present lack of homogeneity in the tone of the facial skin due to hyperchromia caused by sun spots, solar lentigo, post-inflammatory hyperpigmentation, ephelid and mild melasma (proven by Dermatologist)
* Specific for Group 2: Participants who present lack of radiance in the skin (proven by Dermatologist)
* Individual who has signed the informed consent document (ICD) and image disclosure consent term (IDCT)
* Concordance to adhere to the procedures and requirements of the study and to attend the Site on the day(s) and time(s) determined for the evaluations
* For male participants: agree to shave 24 hours before visit 1, 2 and 3
Exclusion Criteria:
* Has known allergies or adverse reactions to common topical skin care products including sunscreen
* Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, active atopic dermatitis, active skin cancer)
* Presents with primary/secondary lesions on test sites (example. scars, ulcers, vesicles, tattoos)
* Report having Type 1 or Type 2 diabetes or taking insulin or another anti-diabetic medication: presents immunological insufficiency; Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including; Immunosuppressive or steroidal drugs within 60 days before Visit 1; Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; Antihistamines within 14 days before Visit 1
* Participants who are currently using or have recently used any facial products containing active skin barrier replacement and intense moisturizing ingredients such as: urea, ceramides, hyaluronic acid, glycerin, butters and oils, within 2 months prior to the start of the study
* Participants who have used cosmetic products for facial and body moisturizing (on the forearms) within 07 days prior to the start of the study
* Specific for Group 2: Participants who are using or have recently used any facial products containing active ingredients against spots: alpha or beta hydroxy acids (including salicylic acid), polyhydroxy acids, topical products containing retinol or retinol derivatives, hydroquinones, arbutin, niacinamide, N-acetylglucosamine, Thiamidol, kojic acid, azelaic acid, licorice extract, whitening peptides, vitamin C, or any other product capable of interfering with the uniformity of skin tone/spots, within 2 months prior to the start of the study
* Participants who have undergone invasive cosmetic or dermatological treatment in the test areas within 2 months prior to the start of the study or during the study
* Participants who are using any medication to treat diseases of the face or body
* Other diseases or medications that may directly interfere with the study or endanger the health of the research participant
* Is self-reported to be pregnant or planning to become pregnant during the study
* Has a history of or a concurrent health/other condition/situation which, in the opinion of the Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Is simultaneously participating in any other study
* Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor
* Presents excessive hair in the evaluation regions that may interfere with the instrumental measurements. In the case of men, they will be instructed to shave 24 hours before the visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05972434
Study Brief:
Protocol Section:
NCT05972434