PhotoagingNCT04835259
Efficacy of Topical Antioxidants in Tretment of Photoaging
A study testing Selenium Amino Acid Chelate (Selenium ACE cream) in people with Photoaging, run by Sohag University.
Trial summary
This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Selenium Amino Acid Chelate (Selenium ACE cream)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jun 2022
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult volunteers < 50 years old
- Clinical and dermoscopic features of photoaging.
Who cannot join
- Genodermatoses associated with photosensitivity.
- Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment.
- Any recent cosmetic procedures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial
This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.
Read the detailed description
•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group.
•Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05
- Conditions
- Photoaging
- Being tested
- Selenium Amino Acid Chelate (Selenium ACE cream)
- Keywords
- topical antioxidants, photoaged skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium Amino Acid Chelate (Selenium ACE cream)Drug
Also called topical retinoid (Acretin 0.05% cream), topical panthenol (Panthenol cream)
application of a topical agent over the whole face for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1(treatment group) | Active comparator | Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt)
Ingredients:
Selenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides) Receives: Drug: Selenium Amino Acid Chelate (Selenium ACE cream) |
| Group 2 (positive control) | Active comparator | Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt) Receives: Drug: Selenium Amino Acid Chelate (Selenium ACE cream) |
| Group 3 (Negative control) | Placebo comparator | Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt) Receives: Drug: Selenium Amino Acid Chelate (Selenium ACE cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Dermoscopy photoaging scale
Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging.
Measured: assesed every month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa ismail, Sohag University
- Investigators
- esraa ismail, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835259
- Sponsor's protocol ID
- Soh-Med-21-01-10
- Status last verified
- Apr 2021
- First submitted
- 19 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04835259
- Acronym / sponsor ID
- Soh-Med-21-01-10
- Conditions
- Photoaging
- Keywords
- topical antioxidants, photoaged skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (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 controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.
Detailed description
•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group.
•Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1(treatment group) | Active comparator | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt) Ingredients: Selenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides) |
| Group 2 (positive control) | Active comparator | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt) |
| Group 3 (Negative control) | Placebo comparator | Drug: Selenium Amino Acid Chelate (Selenium ACE cream)Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult volunteers < 50 years old
- Clinical and dermoscopic features of photoaging.
Key exclusion criteria (3 listed)
- Genodermatoses associated with photosensitivity.
- Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment.
- Any recent cosmetic procedures.
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 |
|---|---|---|
| Selenium Amino Acid Chelate (Selenium ACE cream)Also: topical retinoid (Acretin 0.05% cream), topical panthenol (Panthenol cream)application of a topical agent over the whole face for 6 months | Drug | Group 1(treatment group), Group 2 (positive control), Group 3 (Negative control) |
Primary outcome
change in Dermoscopy photoaging scale
Time frame: assesed every month for 6 months
Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
esraa ismail principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing Selenium Amino Acid Chelate (Selenium ACE cream) in people with Photoaging, run by Sohag University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa ismail (00201000509636, esraasalah123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Dermoscopy photoaging scale (time frame: assesed every month for 6 months). 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 20 Apr 2021.