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

NCT06170346 | Completed Phase 2 DMC

• 1 other identifier: DV-202309.01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodamaged Skin

Keywords

Antioxidants

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Antioxidant

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

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.

Antioxidant

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.

Vehicle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Antioxidants

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Reti Hindritiani, M.D., Ph.D

  Padjadjaran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: November 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

ID (1)