Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced

NCT06170346 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-04-08

No results posted yet for this study

Summary

Ultraviolet (UV) irradiation of the skin leads to acute inflammatory reactions such as erythema, sunburn, and chronic reactions, including premature skin aging and skin tumors. UV irradiation is a potent generator of oxidative stress in the skin. Exposure of mammalian skin to UV increases the cellular levels of reactive oxygen species, which damages lipids, proteins, and nucleic acids in both epidermal and dermal cells and contributes to the sunburn reaction as well as photocarcinogenesis and photoaging. In this study, the effects of a topical antioxidant on attenuating the harmful effects of UV irradiation on normal healthy volunteers were studied using biomarkers of skin damage. This study confirms the protective role of a unique mixture of antioxidants on human skin from the harmful effects of UV irradiation. We propose that antioxidant mixture will complement and synergize with sunscreens in providing photoprotection for human skin.

Conditions

  • Photodamaged Skin

Interventions

COMBINATION_PRODUCT

Antioxidants

30 drops of topical antioxidants (Gluconolactone 4%, Hyaluronic acid 0,01%, Allantoin 0,1%, Ferulic acid 3%, Acetyl heptapeptide 0,001%, Silver vine extract 1%, Ectoine 0,01%, Hydroxyectoine 0,01%, and vehicle) will be applied on tested area on each participant for four consecutive days.

COMBINATION_PRODUCT

Vehicle

30 drops of topical vehicle (Aqua, Dipropylene glycol, Hydroxypropyl cyclodextrin, Polydextrose, 1,2-hexanediol, Butylene glycol, Propanediol, Caprylhydroxamic acid, Ethylhexylglycerin, Xanthan gum, Benzyl alcohol, Glyceryl caprylate, and Benzoic acid) will be applied on tested area on each participant for four consecutive days.

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Reti Hindritiani, M.D., Ph.D · Padjadjaran University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-07-31
Completion
2024-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170346 on ClinicalTrials.gov