PhotoagingNCT07301515
Randomised Controlled Trial of an Antioxidant and Sunscreen Combination Cream for Reducing DNA Damage in Human Skin
A study testing Antioxidant + Sunscreen Cream in people with Photoaging and Photodamage, run by Klira Skin at 1 site in United Kingdom.
Trial summary
This randomized, double-blind, vehicle-controlled clinical trial investigates whether daily use of an encapsulated SPF 50 formulation containing a multi-antioxidant complex provides greater mitochondrial DNA (mtDNA) protection in human facial skin compared with a vehicle-only cream. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Photodamage, Mitochondrial Damage
- What is being tested?
- Antioxidant + Sunscreen Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2025to 10 Nov 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years
- Healthy facial skin with no active dermatologic disease
- Willing to apply the assigned product daily for 12 weeks
- Willing to avoid additional facial skincare products during the study period
- Able to attend baseline and week-12 visits for cheek-swab collection
- Willing to maintain stable medication and supplement use throughout the study
- Provided written informed consent
Who cannot join
- Active facial dermatologic disease or visible facial skin lesions
- Laser, peel, or energy-based facial treatment within the past 3 months
- Use of topical/systemic retinoids, antioxidants, or anti-inflammatory agents within 4 weeks of baseline
- Pregnancy or breastfeeding
- Recent acute illness or infection
- Planned travel to high-UV or sunny destinations during the study period
Show all 10Show fewer
- Current smoker or regular e-cigarette user
- Participation in another clinical trial within the previous 30 days
- Known allergy or sensitivity to study-product ingredients
- Unstable medical conditions or medications known to affect mitochondrial function (e.g., recent changes in antibiotics, statins, or thyroid medication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-Blind, Vehicle-Controlled Trial of a Proprietary Daily Antioxidant + SPF Formulation on Mitochondrial DNA Damage in Human Facial Skin
This randomized, double-blind, vehicle-controlled clinical trial investigates whether daily use of an encapsulated SPF 50 formulation containing a multi-antioxidant complex provides greater mitochondrial DNA (mtDNA) protection in human facial skin compared with a vehicle-only cream.
Fifty-two healthy adults will be enrolled during the UK spring and randomized 1:1 to receive either the antioxidant-enriched SPF 50 or a matched vehicle (no SPF, no antioxidants). Participants will apply their assigned product once daily to the full face for 12 weeks under ambient ultraviolet (UV) and oxidative exposure.
Read more
Non-invasive cheek swabs collected at baseline and week 12 will be analyzed by blinded quantitative polymerase chain reaction (qPCR) to assess mtDNA integrity (ΔCt = Ct_long - Ct_short).
The primary objective is to determine whether the antioxidant-enriched SPF 50 reduces mtDNA damage compared with vehicle. Secondary objectives include comparing the proportion of "responders" showing reduced mtDNA damage (ΔCt < 0) and evaluating within-participant change among habitual daily sunscreen users.
The trial aims to clarify whether adding antioxidants to high-SPF formulations can strengthen daily photoprotection by mitigating residual oxidative stress not fully blocked by UV filters alone.
Read the detailed description
Chronic sun exposure generates oxidative stress that damages both nuclear and mitochondrial DNA in skin cells, contributing to photoaging. Mitochondrial DNA is particularly susceptible to ultraviolet- and reactive-oxygen-mediated injury. Even high-SPF sunscreens only partially prevent oxidative stress from UVA, visible, and infrared wavelengths. Combining topical antioxidants with UV filters may enhance cellular protection, but direct in-vivo evidence of mitochondrial benefit during daily use remains limited.
This single-center, randomized, double-blind, vehicle-controlled study will evaluate the effect of a multi-antioxidant, encapsulated SPF 50 formulation on facial mitochondrial DNA integrity during twelve weeks of normal daily use. The study will be conducted during the UK spring to minimize environmental variability in ultraviolet intensity, temperature, and humidity. Healthy adults aged eighteen to seventy years with intact facial skin will be eligible regardless of baseline sunscreen habits. Individuals with active facial dermatologic disease, recent laser or peel procedures within three months, recent use of retinoids, antioxidants, or anti-inflammatory agents within four weeks, pregnancy, lactation, acute illness, or planned high-UV travel will be excluded. Participants taking medications known to affect mitochondrial function must be on stable doses for at least three months before and throughout the study.
Participants will be randomized in a one-to-one ratio to receive either an encapsulated SPF 50 plus multi-antioxidant complex or a vehicle-only cream containing no SPF and no antioxidants. A small non-randomized comparator group may continue their existing skincare routine to contextualize background variability. Study products will be visually identical, coded, and packaged in identical containers to maintain blinding of participants, investigators, and laboratory staff. Each participant will apply the assigned product once daily to the entire face at a standardized dose of approximately two milligrams per square centimeter for twelve weeks. Adherence will be encouraged through written instructions and monitored by self-report and returned product weight.
At baseline and week twelve, a defined two-by-two-centimeter cheek area will be sampled using a sterile synthetic-tipped swab. Samples will be labeled with coded identifiers and analyzed by a blinded external laboratory using a validated long- and short-amplicon quantitative polymerase chain reaction assay. The mitochondrial DNA integrity index, calculated as ΔCt = Ct_long - Ct_short, reflects lesion frequency, where a negative change indicates improved integrity.
The primary outcome is the change in ΔCt from baseline to week twelve between treatment arms. Secondary outcomes include the proportion of participants with ΔCt < 0, the within-participant change among habitual daily sunscreen users compared with their prior routine, and overall safety and tolerability of both products. Efficacy analyses will include all randomized participants with valid paired baseline and week-twelve data. Between-group comparisons will be performed using two-sided parametric and non-parametric tests, and responder proportions will be compared using Fisher's exact test at a significance level of 0.05.
This study will determine whether daily application of an encapsulated SPF 50 formulation containing multiple antioxidants provides superior mitochondrial protection in facial skin compared with vehicle alone, thereby supporting the concept that antioxidant-enriched sunscreens can enhance photoprotection and reduce oxidative stress encountered in everyday life.
- Conditions
- Photoaging, Photodamage, Mitochondrial Damage, Sunscreen, Antioxidants, Preventive Dermatology
- Being tested
- Antioxidant + Sunscreen Cream, Placebo cream
- Keywords
- Photoprotection, Broad-spectrum SPF 50, Encapsulated UV filters, Mitochondrial DNA, Oxidative stress, Facial skin, Vehicle-controlled trial, Randomized double-blind trial, Red algae extract, Resveratrol (bioferment), Vitamin E (tocopherol), Liquorice extract, Skin barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant + Sunscreen CreamCombination product
Also called Proprietary Antioxidant + SPF Formulation
A daily facial cream containing encapsulated broad-spectrum UV filters (SPF 50+, PA++++) combined with an antioxidant complex composed of Phytexcell Liquorice extract (Glycyrrhiza glabra), Resveratrol bioferment, and Vitamin E (tocopherol). The cream is applied once daily in the morning to the full face (approximately 2 mg/cm²) for 12 weeks.
Placebo creamCombination product
Also called Vehicle cream
An identical-appearing vehicle cream without UV filters or antioxidant actives. The base formulation, texture, and packaging are identical to the active product. Applied once daily in the morning to the full face (approximately 2 mg/cm²) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant + Sunscreen Cream | Experimental | Participants apply a daily facial cream containing encapsulated broad-spectrum UV filters (SPF 50+, PA++++) combined with an antioxidant complex composed of Phytexcell Liquorice extract (Glycyrrhiza glabra), Resveratrol bioferment, and Vitamin E (tocopherol). The cream is applied once daily in the morning to the full face for 12 weeks. Receives: Combination Product: Antioxidant + Sunscreen Cream |
| Vehicle-Only Cream | Placebo comparator | Participants apply an identical-appearing vehicle cream without UV filters, or antioxidants. The product base, texture, and packaging are identical to the active formulation. It is applied once daily in the morning to the full face for 12 weeks. Receives: Combination Product: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Mitochondrial DNA Damage (ΔCt) Between Active and Vehicle Creams Measured by Long-Amplicon Quantitative PCR
Mitochondrial DNA (mtDNA) integrity will be assessed from non-invasive cheek swabs using long-amplicon quantitative polymerase chain reaction (qPCR). Two mtDNA fragments are amplified: a long fragment (damage-sensitive) and a short fragment (control for total DNA). ΔCt ("delta-Ct") = Ct_long - Ct_short, where higher values indicate greater mtDNA damage. For each participant, the change in ΔCt from baseline to Week 12 will be calculated. The primary outcome is the between-group difference in this change (Active minus Vehicle), adjusted for baseline values. Negative values denote reduced mtDNA damage with the antioxidant + SPF formulation. Laboratory staff and statisticians are blinded to allocation.
Measured: Baseline to Week 12
Secondary outcomes (4)
Proportion of Participants With Reduced Mitochondrial DNA Damage (ΔCt < 0)
Participants will be classified as "responders" if their change in ΔCt from baseline to Week 12 is < 0, indicating reduced mtDNA damage. The proportion of responders will be compared between randomized arms. Analyses are blinded.
Measured: Baseline to Week 12
Change in Mitochondrial DNA Damage (ΔCt) From Baseline to Week 12 Among Habitual Daily Sunscreen Users - Active Arm
Among participants who reported daily sunscreen use at baseline, change in ΔCt from baseline (reflecting prior sunscreen routine) to Week 12 will be analyzed while using the antioxidant + SPF 50 cream. Negative change denotes less mtDNA damage at Week 12. Paired, blinded analysis.
Measured: Baseline to Week 12
Change in Mitochondrial DNA Damage (ΔCt) From Baseline to Week 12 Among Habitual Daily Sunscreen Users - Vehicle Arm
Among participants who reported daily sunscreen use at baseline, change in ΔCt from baseline (reflecting prior sunscreen routine) to Week 12 will be analyzed while using the vehicle cream without SPF or antioxidants. Positive change denotes greater mtDNA damage at Week 12. Paired, blinded analysis.
Measured: Baseline to Week 12
Tolerability and Participant-Reported Cosmetic Acceptability
Participants will complete structured questionnaires on tolerability (stinging, burning, redness, dryness, breakouts) and cosmetic acceptability (overall appearance, evenness, brightness, texture, and willingness to continue). Change from baseline will be summarized by treatment group. Assessments are blinded to allocation.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Mar 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a parallel assignment to receive either an encapsulated SPF 50 plus multi-antioxidant cream (active) or a vehicle-only cream (comparator). A small, non-randomized observational group continues their usual skincare routine and/or sunscreen use to provide contextual background data. Randomization uses computer-generated block sequences with allocation concealment. Both participants and investigators are blinded to treatment assignment for the randomized arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klira Skin
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Skin Analytics Limited
- Responsible party
- Sponsor
- Investigators
- Emma Craythorne, Medicine MBChB, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301515
- Sponsor's protocol ID
- KLR-MITO-2025-01
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be shared, including mtDNA ΔCt values (baseline and week 12), treatment assignment, age, and habitual sunscreen-use category. Questionnaire outcome data and adverse event information will also be available. The shared dataset will exclude all direct identifiers and any genomic sequence data beyond ΔCt metrics.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-Blind, Vehicle-Controlled Trial of a Proprietary Daily Antioxidant + SPF Formulation on Mitochondrial DNA Damage in Human Facial Skin
- ClinicalTrials.gov ID
- NCT07301515
- Acronym / sponsor ID
- KLR-MITO-2025-01
- Conditions
- Photoaging, Photodamage, Mitochondrial Damage, Sunscreen, Antioxidants, Preventive Dermatology
- Keywords
- Photoprotection, Broad-spectrum SPF 50, Encapsulated UV filters, Mitochondrial DNA, Oxidative stress, Facial skin, Vehicle-controlled trial, Randomized double-blind trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Klira SkinUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Skin Analytics Limited
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 24 Dec 2025 (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.
This randomized, double-blind, vehicle-controlled clinical trial investigates whether daily use of an encapsulated SPF 50 formulation containing a multi-antioxidant complex provides greater mitochondrial DNA (mtDNA) protection in human facial skin compared with a vehicle-only cream.
Fifty-two healthy adults will be enrolled during the UK spring and randomized 1:1 to receive either the antioxidant-enriched SPF 50 or a matched vehicle (no SPF, no antioxidants). Participants will apply their assigned product once daily to the full face for 12 weeks under ambient ultraviolet (UV) and oxidative exposure.
Non-invasive cheek swabs collected at baseline and week 12 will be analyzed by blinded quantitative polymerase chain reaction (qPCR) to assess mtDNA integrity (ΔCt = Ct_long - Ct_short).
The primary objective is to determine whether the antioxidant-enriched SPF 50 reduces mtDNA damage compared with vehicle. Secondary objectives include comparing the proportion of "responders" showing reduced mtDNA damage (ΔCt < 0) and evaluating within-participant change among habitual daily sunscreen users.
The trial aims to clarify whether adding antioxidants to high-SPF formulations can strengthen daily photoprotection by mitigating residual oxidative stress not fully blocked by UV filters alone.
Detailed description
Chronic sun exposure generates oxidative stress that damages both nuclear and mitochondrial DNA in skin cells, contributing to photoaging. Mitochondrial DNA is particularly susceptible to ultraviolet- and reactive-oxygen-mediated injury. Even high-SPF sunscreens only partially prevent oxidative stress from UVA, visible, and infrared wavelengths. Combining topical antioxidants with UV filters may enhance cellular protection, but direct in-vivo evidence of mitochondrial benefit during daily use remains limited.
This single-center, randomized, double-blind, vehicle-controlled study will evaluate the effect of a multi-antioxidant, encapsulated SPF 50 formulation on facial mitochondrial DNA integrity during twelve weeks of normal daily use. The study will be conducted during the UK spring to minimize environmental variability in ultraviolet intensity, temperature, and humidity. Healthy adults aged eighteen to seventy years with intact facial skin will be eligible regardless of baseline sunscreen habits. Individuals with active facial dermatologic disease, recent laser or peel procedures within three months, recent use of retinoids, antioxidants, or anti-inflammatory agents within four weeks, pregnancy, lactation, acute illness, or planned high-UV travel will be excluded. Participants taking medications known to affect mitochondrial function must be on stable doses for at least three months before and throughout the study.
Participants will be randomized in a one-to-one ratio to receive either an encapsulated SPF 50 plus multi-antioxidant complex or a vehicle-only cream containing no SPF and no antioxidants. A small non-randomized comparator group may continue their existing skincare routine to contextualize background variability. Study products will be visually identical, coded, and packaged in identical containers to maintain blinding of participants, investigators, and laboratory staff. Each participant will apply the assigned product once daily to the entire face at a standardized dose of approximately two milligrams per square centimeter for twelve weeks. Adherence will be encouraged through written instructions and monitored by self-report and returned product weight.
At baseline and week twelve, a defined two-by-two-centimeter cheek area will be sampled using a sterile synthetic-tipped swab. Samples will be labeled with coded identifiers and analyzed by a blinded external laboratory using a validated long- and short-amplicon quantitative polymerase chain reaction assay. The mitochondrial DNA integrity index, calculated as ΔCt = Ct_long - Ct_short, reflects lesion frequency, where a negative change indicates improved integrity.
The primary outcome is the change in ΔCt from baseline to week twelve between treatment arms. Secondary outcomes include the proportion of participants with ΔCt < 0, the within-participant change among habitual daily sunscreen users compared with their prior routine, and overall safety and tolerability of both products. Efficacy analyses will include all randomized participants with valid paired baseline and week-twelve data. Between-group comparisons will be performed using two-sided parametric and non-parametric tests, and responder proportions will be compared using Fisher's exact test at a significance level of 0.05.
This study will determine whether daily application of an encapsulated SPF 50 formulation containing multiple antioxidants provides superior mitochondrial protection in facial skin compared with vehicle alone, thereby supporting the concept that antioxidant-enriched sunscreens can enhance photoprotection and reduce oxidative stress encountered in everyday life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a parallel assignment to receive either an encapsulated SPF 50 plus multi-antioxidant cream (active) or a vehicle-only cream (comparator). A small, non-randomized observational group continues their usual skincare routine and/or sunscreen use to provide contextual background data. Randomization uses computer-generated block sequences with allocation concealment. Both participants and investigators are blinded to treatment assignment for the randomized arms.
| Arm | Type | Receives |
|---|---|---|
| Antioxidant + Sunscreen Cream | Experimental | Combination Product: Antioxidant + Sunscreen CreamParticipants apply a daily facial cream containing encapsulated broad-spectrum UV filters (SPF 50+, PA++++) combined with an antioxidant complex composed of Phytexcell Liquorice extract (Glycyrrhiza glabra), Resveratrol bioferment, and Vitamin E (tocopherol). The cream is applied once daily in the morning to the full face for 12 weeks. |
| Vehicle-Only Cream | Placebo comparator | Combination Product: Placebo creamParticipants apply an identical-appearing vehicle cream without UV filters, or antioxidants. The product base, texture, and packaging are identical to the active formulation. It is applied once daily in the morning to the full face for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-80 years
- Healthy facial skin with no active dermatologic disease
- Willing to apply the assigned product daily for 12 weeks
- Willing to avoid additional facial skincare products during the study period
- Able to attend baseline and week-12 visits for cheek-swab collection
Key exclusion criteria (10 listed)
- Active facial dermatologic disease or visible facial skin lesions
- Laser, peel, or energy-based facial treatment within the past 3 months
- Use of topical/systemic retinoids, antioxidants, or anti-inflammatory agents within 4 weeks of baseline
- Pregnancy or breastfeeding
- Recent acute illness or infection
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 |
|---|---|---|
| Antioxidant + Sunscreen CreamAlso: Proprietary Antioxidant + SPF FormulationA daily facial cream containing encapsulated broad-spectrum UV filters (SPF 50+, PA++++) combined with an antioxidant complex composed of Phytexcell Liquorice extract (Glycyrrhiza glabra), Resveratrol bioferment, and Vitamin E (tocopherol). The cream is applied once daily in the morning to the full face (approximately 2 mg/cm²) for 12 weeks. | Combination product | Antioxidant + Sunscreen Cream |
| Placebo creamAlso: Vehicle creamAn identical-appearing vehicle cream without UV filters or antioxidant actives. The base formulation, texture, and packaging are identical to the active product. Applied once daily in the morning to the full face (approximately 2 mg/cm²) for 12 weeks. | Combination product | Vehicle-Only Cream |
Primary outcome
Difference in Change in Mitochondrial DNA Damage (ΔCt) Between Active and Vehicle Creams Measured by Long-Amplicon Quantitative PCR
Time frame: Baseline to Week 12
Mitochondrial DNA (mtDNA) integrity will be assessed from non-invasive cheek swabs using long-amplicon quantitative polymerase chain reaction (qPCR). Two mtDNA fragments are amplified: a long fragment (damage-sensitive) and a short fragment (control for total DNA). ΔCt ("delta-Ct") = Ct_long - Ct_short, where higher values indicate greater mtDNA damage. For each participant, the change in ΔCt from baseline to Week 12 will be calculated. The primary outcome is the between-group difference in this change (Active minus Vehicle), adjusted for baseline values. Negative values denote reduced mtDNA damage with the antioxidant + SPF formulation. Laboratory staff and statisticians are blinded to allocation.
4 secondary outcomes
Proportion of Participants With Reduced Mitochondrial DNA Damage (ΔCt < 0)
Time frame: Baseline to Week 12
Change in Mitochondrial DNA Damage (ΔCt) From Baseline to Week 12 Among Habitual Daily Sunscreen Users - Active Arm
Time frame: Baseline to Week 12
Change in Mitochondrial DNA Damage (ΔCt) From Baseline to Week 12 Among Habitual Daily Sunscreen Users - Vehicle Arm
Time frame: Baseline to Week 12
Tolerability and Participant-Reported Cosmetic Acceptability
Time frame: Baseline to Week 12
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be shared, including mtDNA ΔCt values (baseline and week 12), treatment assignment, age, and habitual sunscreen-use category. Questionnaire outcome data and adverse event information will also be available. The shared dataset will exclude all direct identifiers and any genomic sequence data beyond ΔCt metrics.
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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.
Emma Craythorne, Medicine MBChB principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant + Sunscreen Cream in people with Photoaging and Photodamage, run by Klira Skin at 1 site in United Kingdom.
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 7 inclusion and 10 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 24 Dec 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 United Kingdom. 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.
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?
Difference in Change in Mitochondrial DNA Damage (ΔCt) Between Active and Vehicle Creams Measured by Long-Amplicon Quantitative PCR (time frame: Baseline to Week 12). 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 24 Dec 2025.