Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Antioxidants

+ Vehicle

Combination Product
Who is being recruted

From 18 to 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorUniversitas Padjadjaran
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2022

Actual date on which the first participant was enrolled.

This clinical trial is exploring how different topical antioxidant ingredients can help protect skin from damage caused by UVB rays from the sun. UVB rays can lead to skin issues like sunburn, DNA damage, and even skin cancer over time. Antioxidants are known to combat these harmful effects by neutralizing harmful molecules called Reactive Oxygen Species (ROS) that are produced when skin is exposed to UVB rays. This study is particularly important because it investigates new combinations of antioxidants, such as gluconolactone, hyaluronic acid, and others, to see if they can reduce skin damage better than current treatments. Understanding these effects could lead to improved skincare products that offer better protection against sun damage. Participants in this study will apply topical treatments containing various antioxidants to their skin, and researchers will measure the effects by examining markers of skin damage, such as thymine dimers and p53 protein expression, which are indicators of sun-induced harm. The study compares these antioxidant-rich treatments to a control substance to evaluate their effectiveness. By observing these outcomes, researchers aim to determine how well these antioxidants can prevent or repair damage caused by UVB exposure. This information could help develop more effective skincare options for preventing sun damage.

Official TitleThe Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced by Ultraviolet B Radiation
NCT06170346
Principal SponsorUniversitas Padjadjaran
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Males and females aged 18-60 years.
Skin types III and IV according to Fitzpatrick.
Normal back skin.
5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hasan Sadikin General Hospital

Bandung, IndonesiaOpen Hasan Sadikin General Hospital in Google Maps
CompletedOne Study Center
The Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced by Ultraviolet B Radiation | PatLynk