NCT07401342

An Assessment of the Efficacy and Safety of Employing a Duosomal Chemical Peel for Aesthetic Enhancement in the Periocular and Facial Regions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will employ an experimental, prospective, longitudinal, and comparative before-and-after design. The objective is to assess the efficacy and safety of duosomal chemical peels as agents for enhancing the aesthetic appearance of the periocular and facial regions

Detailed description

Participants aged over 21 years will be included in the study. They will receive an application of salicylic acid to the facial surface through continuous massaging for a duration of five minutes, facilitating the exfoliation of the superficial epidermal layers. Subsequently, a specific medication will be administered based on the skin characteristics and the intended treatment objective: salicylic acid for individuals predisposed to oily skin and acne, mandelic acid for those with irregular pigmentation and hyperpigmentation, lactic acid for individuals with sensitive skin, and glycolic acid for those with wrinkles and pigmentation changes due to aging. A moisturizer will then be applied and massaged continuously, allowing it to act for five minutes. These treatments will be administered weekly over a four-week period. Improvement as reported by the study participants will be evaluated using the Face-Q and SASSQ (Scientific Assessment Scale of Skin Quality) questionnaires. The SASSQ is an objective scale completed by the researcher, assessing loss of elasticity, wrinkles, roughness, pigmentation, erythema, and pore size on a scale from 0 to 4, where 0 denotes absence of the parameter and 4 indicates very severe changes. The FACE-Q is a subjective scale completed by the participants, ranging from 1 to 4, where 1 signifies very dissatisfied and 4 signifies very satisfied. Descriptive statistics of the demographic variables will be conducted, and analytical statistics using the Wilcoxon test will be employed to compare baseline and final results at the conclusion of the treatment. A p-value of less than 0.05 will be considered statistically significant.

Conditions

• Chemical Peeling

Interventions

Type	Name	Description
DRUG	Duosomal chemical peel application	They will receive an application of salicylic acid to the facial surface through continuous massaging for a duration of five minutes, facilitating the exfoliation of the superficial epidermal layers. Subsequently, a specific medication will be administered based on the skin characteristics and the intended treatment objective: salicylic acid for individuals predisposed to oily skin and acne, mandelic acid for those with irregular pigmentation and hyperpigmentation, lactic acid for individuals with sensitive skin, and glycolic acid for those with wrinkles and pigmentation changes due to aging. A moisturizer will then be applied and massaged continuously, allowing it to act for five minutes. These treatments will be administered weekly over a four-week period.

Timeline

• Start date: 2023-11-01
• Primary completion: 2023-12-28
• Completion: 2024-01-31
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Mexico