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Completed

NCT Number: NCT06170346

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

Photoprotection is an effort made to reduce the detrimental effects of Reactive Oxygen Species (ROS) on the skin due to UVB exposure. Photoprotection consists of primary and secondary. Lifestyle modification, physical photoprotection and sunscreen use are parts of primary photoprotection. Secondary photoprotection is the use of agents or ingredients that serve to reduce the adverse effects of sunlight reaching the skin. Examples of secondary photoprotection are antioxidants. Antioxidants are compounds that in low levels react with oxidized substrates by providing electrons. These compounds can prevent and neutralize the negative impact of ROS on the skin due to UVB exposure, one of which is minimizing photoaging. UVB exposure can produce ROS that trigger erythema in subjects, the formation of DNA damage in the form of thymine dimers, the discovery of sunburn cells and can activate p53, and MMP-9 enzymes. Acute photodamage is characterized by the formation of sunburn cells and chronically can lead to malignancy. Photoprotection can be used to reduce these effects. One of the photoprotection efforts is the use of antioxidants, which are secondary photoprotective agents that prevent or repair skin damage caused by ROS. In previous studies, topical ingredients containing vitamin C, vitamin E, and ferulic acid have a photoprotective effect against UVB-induced skin photodamage characterized by decreased expression of thymine dimer and p53 in the skin. Various studies on the combined effects of antioxidant ingredients are still being developed. Currently, there is no research on the effect of topical ingredients containing various antioxidants, namely gluconolactone, hyaluronic acid, allantoin, ferulic acid, acetyl heptapeptide, silver vine extract, ectoine, and hydroxyectoine on skin photodamage. For this reason, it is necessary to conduct research on the effects of topical ingredients containing various antioxidants on the expression of thymine dimer and p53 in UVB-induced skin compared to vehiculum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18-60 years.
  • Skin types III and IV according to Fitzpatrick.
  • Normal back skin.

Exclusion criteria

  • Pregnant and lactating women.
  • History of photodermatosis, skin malignancies, skin diseases that can be exacerbated by light.
  • History of sun exposure to the back area in the past two weeks.
  • History of applying and taking antioxidants containing gluconolactone, hyaluronic acid, allantoin, ferulic acid, acetyl heptapeptide, silver vine extract, ectoine, and hydroxyectoine in the past 12 weeks.
  • History of taking photosensitizer drugs (malaria drugs, analgesics, antidepressants, systemic fungal drugs, chemotherapy) in the past eight weeks.

Treatment and study plan

Antioxidants

Combination Product

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.

Vehicle

Combination Product

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.

Primary outcomes

  1. Erythema intensity

    Time frame: 1 day

    Assessment of the erythema intensity using a spectrophotometer

  2. Sunburn cells

    Time frame: 1 day

    Assessment of sunburn cells numbers in epidermis from skin tissue stained using Hematoxylin Eosin.

  3. MMP-9 expression

    Time frame: 1 day

    Assessment of MMP-9 expression in epidermis from skin tissue stained using Immunohistochemistry.

  4. p53 expression

    Time frame: 1 day

    Assessment of p53 expression in epidermis from skin tissue stained using Immunohistochemistry.

  5. Thymine dimer expression

    Time frame: 1 day

    Assessment of thymine dimer expression in epidermis from skin tissue stained using Immunohistochemistry.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

The Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced by Ultraviolet B Radiation

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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