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

NCT ID: NCT06170346

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-01-31

Brief 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.

Detailed Description

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.

Conditions

Photodamaged Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Antioxidant

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. On the fifth day, the subject will be irradiated on the tested area. After irradiation, erythema intensity and skin biopsy will be taken. Furthermore, skin tissue will be stained to see sunburn cells and assesses the expression of MMP-9, Thymine Dimer, and p-53 by immunohistochemistry.

Group Type: EXPERIMENTAL

Antioxidants

Intervention Type: 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

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. On the fifth day, the subject will be irradiated on the tested area. After irradiation, erythema intensity and skin biopsy will be taken. Furthermore, skin tissue will be stained to see sunburn cells and assesses the expression of MMP-9, Thymine Dimer, and p-53 by immunohistochemistry.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: 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.

Control

Skin without intervention and irradiation. Skin biopsy will be taken as a control. Skin tissue will be stained to see sunburn cells and assesses the expression of MMP-9, Thymine Dimer, and p-53 by immunohistochemistry.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reti Hindritiani, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Padjadjaran University

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

DV-202309.01

Identifier Type: -

Identifier Source: org_study_id