Skin aging and wrinkles.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Individuals seeking skin care treatments aged 18 years and older, without any diagnosed dermatologic disorders confirmed by a physician or documented in their medical records. Provision of written informed consent. A required washout period must be observed for certain topical dermatologic medications (such as retinoids, exfoliating acids, topical corticosteroids, etc.), as follows:Topical retinoids: At least 4 weeks of discontinuation prior to enrollment.Laser therapy, dermal fillers, or botulinum toxin injections: At least 6 months must have passed since the last procedure.
Exclusion criteria
Exclusion criteria: Serious or unacceptable skin reactions (e.g., severe erythema, blistering, or severe contact dermatitis) requiring discontinuation of treatment or medical intervention. Systemic adverse effects determined to be related to the investigational product and considered to make continued participation unsafe. Change in medical condition or initiation of a new medication that may interfere with the study or compromise participant safety (e.g., initiation of isotretinoin or systemic corticosteroids). Pregnancy or breastfeeding during the study period (including a positive pregnancy test or self-reported pregnancy). Non-compliance with the study protocol (e.g., repeated use of prohibited products or failure to attend key study visits) to an extent that renders the data unreliable. Voluntary withdrawal: Participants may withdraw from the study at any time without providing a reason. Loss to follow-up, defined as missing multiple consecutive visits according to the study protocol (e.g., absence from two consecutive visits). New laboratory or clinical findings for which the principal investigator or ethics committee determines that continued participation would be unsafe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome 1: Reduction in mean skin wrinkle depth in the intervention area compared to the control area. This variable is measured using a skin analyzer at baseline (day 0), week 2, and week 4, and the unit of measurement is micrometers (µm).Primary Outcome. Timepoint: Baseline (before intervention), 2 weeks after intervention, and 4 weeks after intervention. Method of measurement: Measurement using a Skin Analyzer device capable of three-dimensional scanning of the skin surface and calculating wrinkle parameters including depth, number, and area of wrinkles. | — |
Countries
Iran (Islamic Republic of)
Contacts
Iran University of Medical Sciences