Photodamaged SkinPhase 2NCT06170346
Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced
A Phase 2 study testing Antioxidants in people with Photodamaged Skin, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Antioxidants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2022to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18-60 years.
- Skin types III and IV according to Fitzpatrick.
- Normal back skin.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Antioxidants, Vehicle
- Keywords
- Antioxidants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantsCombination 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.
VehicleCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema intensity
Assessment of the erythema intensity using a spectrophotometer
Measured: 1 day
Sunburn cells
Assessment of sunburn cells numbers in epidermis from skin tissue stained using Hematoxylin Eosin.
Measured: 1 day
MMP-9 expression
Assessment of MMP-9 expression in epidermis from skin tissue stained using Immunohistochemistry.
Measured: 1 day
p53 expression
Assessment of p53 expression in epidermis from skin tissue stained using Immunohistochemistry.
Measured: 1 day
Thymine dimer expression
Assessment of thymine dimer expression in epidermis from skin tissue stained using Immunohistochemistry.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reti Hindritiani, M.D., Ph.D, Principal investigator, Padjadjaran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170346
- Sponsor's protocol ID
- DV-202309.01
- Status last verified
- Apr 2025
- First submitted
- 6 Dec 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced by Ultraviolet B Radiation
- ClinicalTrials.gov ID
- NCT06170346
- Acronym / sponsor ID
- DV-202309.01
- Conditions
- Photodamaged Skin
- Keywords
- Antioxidants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antioxidant | Experimental | Combination Product: Antioxidants30 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. |
| Vehicle | Placebo comparator | Combination Product: Vehicle30 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females aged 18-60 years.
- Skin types III and IV according to Fitzpatrick.
- Normal back skin.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidants30 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. | Combination product | Antioxidant |
| Vehicle30 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. | Combination product | Vehicle |
Primary outcome
Erythema intensity
Time frame: 1 day
Assessment of the erythema intensity using a spectrophotometer
Sunburn cells
Time frame: 1 day
Assessment of sunburn cells numbers in epidermis from skin tissue stained using Hematoxylin Eosin.
MMP-9 expression
Time frame: 1 day
Assessment of MMP-9 expression in epidermis from skin tissue stained using Immunohistochemistry.
p53 expression
Time frame: 1 day
Assessment of p53 expression in epidermis from skin tissue stained using Immunohistochemistry.
Thymine dimer expression
Time frame: 1 day
Assessment of thymine dimer expression in epidermis from skin tissue stained using Immunohistochemistry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
Not yet recruitingPhase 2/3
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Not yet recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Photodamaged Skin, Skin Cancer Prevention
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reti Hindritiani, M.D., Ph.D principal investigator
Padjadjaran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antioxidants in people with Photodamaged Skin, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema intensity (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.