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Chemical PeelingPhase 4AESEDCPAEPFRNCT07401342

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

A Phase 4 study testing Duosomal chemical peel application in people with Chemical Peeling, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chemical Peeling
What is being tested?
Duosomal chemical peel application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteMexico
Study dates
1 Nov 2023to 31 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

    Mexico City, Mexico City, 06800

Other trials in Mexico

About this study

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

Read the 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.

Being tested
Duosomal chemical peel application
Keywords
Chemoexfoliation, Skin Resurfacing, Topical Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duosomal chemical peel applicationDrug

    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.

Study groups in NCT07401342
Study groupRoleWhat they receive
Participants aged over 21 years included in the studyExperimentalThey 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
Receives: Drug: Duosomal chemical peel application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From enrollment to the end of treatment at 4 weeks

  2. 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

    Measured: From enrollment to the end of treatment at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start1 Nov 2023
  3. Primary completion28 Dec 2023
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07401342
Sponsor's protocol ID
CEI-2023/11/02
Acronym
AESEDCPAEPFR
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Garg VK, Sinha S, Sarkar R. Glycolic acid peels versus salicylic-mandelic acid peels in active acne vulgaris and post-acne scarring and hyperpigmentation: a comparative study. Dermatol Surg. 2009 Jan;35(1):59-65. doi: 10.1111/j.1524-4725.2008.34383.x. Epub 2008 Dec 8.

    PubMed 19076192
  • Nsairat H, Khater D, Sayed U, Odeh F, Al Bawab A, Alshaer W. Liposomes: structure, composition, types, and clinical applications. Heliyon. 2022 May 13;8(5):e09394. doi: 10.1016/j.heliyon.2022.e09394. eCollection 2022 May.

    PubMed 35600452
  • Lasic DD, Papahadjopoulos D. Liposomes revisited. Science. 1995 Mar 3;267(5202):1275-6. doi: 10.1126/science.7871422. No abstract available.

    PubMed 7871422
  • Andra VVSNL, Pammi SVN, Bhatraju LVKP, Ruddaraju LK. A Comprehensive Review on Novel Liposomal Methodologies, Commercial Formulations, Clinical Trials and Patents. Bionanoscience. 2022;12(1):274-291. doi: 10.1007/s12668-022-00941-x. Epub 2022 Jan 26.

    PubMed 35096502
  • 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.

    PubMed 26859648
  • 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.

    PubMed 36117771
  • Grimes PE. The safety and efficacy of salicylic acid chemical peels in darker racial-ethnic groups. Dermatol Surg. 1999 Jan;25(1):18-22. doi: 10.1046/j.1524-4725.1999.08145.x.

    PubMed 9935087
  • Sharquie KE, Al-Tikreety MM, Al-Mashhadani SA. Lactic acid chemical peels as a new therapeutic modality in melasma in comparison to Jessner's solution chemical peels. Dermatol Surg. 2006 Dec;32(12):1429-36. doi: 10.1111/j.1524-4725.2006.32352.x.

    PubMed 17199649
  • Jarzabek-Perz S, Mucha P, Rotsztejn H. Corneometric evaluation of skin moisture after application of 10% and 30% gluconolactone. Skin Res Technol. 2021 Sep;27(5):925-930. doi: 10.1111/srt.13044. Epub 2021 Mar 26.

    PubMed 33769633
  • 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.

    PubMed 31553119
  • Yamamoto K, Oishi K, Fujimatsu I, Komatsu K. Production of R-(-)-mandelic acid from mandelonitrile by Alcaligenes faecalis ATCC 8750. Appl Environ Microbiol. 1991 Oct;57(10):3028-32. doi: 10.1128/aem.57.10.3028-3032.1991.

    PubMed 1660699
  • 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.

    PubMed 29064096
  • 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.

    PubMed 37806681
  • Salam A, Dadzie OE, Galadari H. Chemical peeling in ethnic skin: an update. Br J Dermatol. 2013 Oct;169 Suppl 3:82-90. doi: 10.1111/bjd.12535.

    PubMed 24098904
  • Gentili G, Perugini P, Bugliaro S, D'Antonio C. Efficacy and safety of a new peeling formulated with a pool of PHAs for the treatment of all skin types, even sensitive. J Cosmet Dermatol. 2023 Feb;22(2):517-528. doi: 10.1111/jocd.15215. Epub 2022 Aug 9.

    PubMed 35796684

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duosomal chemical peel application in people with Chemical Peeling, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective skin quality improvement (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07401342, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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