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

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

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.

Study Overview

• Status: Completed
• Conditions: Photodamaged Skin
• Intervention / Treatment: Combination product: Antioxidants; Combination product: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema intensity	Assessment of the erythema intensity using a spectrophotometer	1 day
Sunburn cells	Assessment of sunburn cells numbers in epidermis from skin tissue stained using Hematoxylin Eosin.	1 day
MMP-9 expression	Assessment of MMP-9 expression in epidermis from skin tissue stained using Immunohistochemistry.	1 day
p53 expression	Assessment of p53 expression in epidermis from skin tissue stained using Immunohistochemistry.	1 day
Thymine dimer expression	Assessment of thymine dimer expression in epidermis from skin tissue stained using Immunohistochemistry.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin biopsy and Hematoxylin Eosin	Assess the presence of sunburn cells from skin biopsies, then stained using Hematoxylin Eosin.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin biopsi and immunohistochemical	Assess the MMP-9, Thymine dimer, and p53 from skin biopsies, then then subjected to immunohistochemical examination	1 day

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Reti Hindritiani, M.D., Ph.D, Padjadjaran University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Antioxidants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: DV-202309.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No