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

NCT07401342 | Completed Phase 4 DMC

• 1 other identifier: CEI-2023/11/02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chemical Peeling

Keywords

Chemoexfoliation; Skin Resurfacing; Topical Treatment

Outcome Measures

Primary Outcomes (2)

• Objective skin quality improvement

  The SASSQ (Scientific Assessment Scale of Skin Quality) 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

  From enrollment to the end of treatment at 4 weeks

• Subjective skin quality improvement

  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

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Participants aged over 21 years included in the study

EXPERIMENTAL

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

Drug: Duosomal chemical peel application

Interventions

Duosomal chemical peel application DRUG

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.

Participants aged over 21 years included in the study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 21 years and older, both male and female, who seek enhancement of the periocular and facial regions will be considered for recruitment. Participants must agree to the study conditions, consent to the follow-up period as proposed, and provide informed consent for the procedure.

You may not qualify if:

• Individuals with psychiatric disorders, those exhibiting symptoms indicative of body dysmorphia, and those who have undergone facial filler treatments within the six months preceding the procedure. Elimination criteria: Participants who fail to adhere to follow-up protocols during the designated periods; those who receive additional treatments such as mesotherapy, botulinum toxin, chemical peeling, or facial fillers in the same area during the follow-up period; and those who, during the follow-up period, develop any debilitating illness or conditions resulting in a wasting/emaciation syndrome.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, 06800, Mexico

Location

Related Publications (22)

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• Sarkar R, Garg V, Bansal S, Sethi S, Gupta C. Comparative Evaluation of Efficacy and Tolerability of Glycolic Acid, Salicylic Mandelic Acid, and Phytic Acid Combination Peels in Melasma. Dermatol Surg. 2016 Mar;42(3):384-91. doi: 10.1097/DSS.0000000000000642.

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• Odrzywolek W, Deda A, Zdrada J, Wilczynski S, Blonska-Fajfrowska B, Lipka-Trawinska A. Quantitative Evaluation of the Effectiveness of Chemical Peelings in Reducing Acne Lesions Based on Gray-Level Co-Occurrence Matrix (GLCM). Clin Cosmet Investig Dermatol. 2022 Sep 12;15:1873-1882. doi: 10.2147/CCID.S375131. eCollection 2022.

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• Dayal S, Kalra KD, Sahu P. Comparative study of efficacy and safety of 45% mandelic acid versus 30% salicylic acid peels in mild-to-moderate acne vulgaris. J Cosmet Dermatol. 2020 Feb;19(2):393-399. doi: 10.1111/jocd.13168. Epub 2019 Sep 25.

  PMID: 31553119 RESULT

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  PMID: 1660699 RESULT

• O'Connor AA, Lowe PM, Shumack S, Lim AC. Chemical peels: A review of current practice. Australas J Dermatol. 2018 Aug;59(3):171-181. doi: 10.1111/ajd.12715. Epub 2017 Oct 24.

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• Bensimon RH. Chemical Peels. Facial Plast Surg Clin North Am. 2023 Nov;31(4):475-494. doi: 10.1016/j.fsc.2023.05.006. Epub 2023 Jul 26.

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• Asilian A, Shahmoradi Z, Talakoub M, Mokhtari F, Siadat AH, Mohaghegh F, Adibi N, Mozafarpoor S, Kazemipour S, Danesh F, Hafezi H. Evaluation of combination therapy with peeling added to minimal invasive blepharoplasty in lower eyelid rejuvenation. J Cosmet Dermatol. 2020 Nov;19(11):2922-2928. doi: 10.1111/jocd.13394. Epub 2020 Apr 3.

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  PMID: 34889041 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: November 1, 2023
• Primary Completion: December 28, 2023
• Study Completion: January 31, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From May to July 2026

Locations

ME (1)