PhotoagingNCT05882084
Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
A study testing Astaxanthin 6 mg daily in people with Photoaging, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
This study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Astaxanthin 6 mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 31 Dec 2023
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females who are 30 to 55 years of age
- Half of the women will have Fitzpatrick skin type 1-3 and the other half of the women will have Fitzpatrick skin type 4-6
Who cannot join
- Individuals with a known allergy to astaxanthin or other carotenoids (such as zeaxanthin, lutein, lycopene).
- Individuals who are unwilling to discontinue carotenoid supplementation for at least 1 month prior to enrollment
- Individuals unwilling to restrict intake of foods like shrimp, salmon, mangos, carrots, and tomatoes during the study.
- New supplementation within 4 weeks with tocopherol
- Individuals who are unwilling to stay consistent with a facial cleansing regimen.
- Those who are unwilling to discontinue topical hydroquinone, retinoid or benzoyl peroxide for 2 weeks prior to enrollment
Show all 9Show fewer
- Individuals who are pregnant or breastfeeding.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95819
Nasima Afzal, 916-750-2463, nasima@integrativeskinresearch.com
About this study
Official title: Double Blind Placebo Controlled Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
This study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness.
- Conditions
- Photoaging
- Being tested
- Astaxanthin 6 mg daily, Placebo
- Keywords
- Carotenoid, Astaxanthin, Skin, Hydration, Elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin 6 mg dailyDietary supplement
Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | 6 mg daily Receives: Dietary Supplement: Astaxanthin 6 mg daily |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Hydration
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
Measured: 8 weeks
Skin elasticity
Skin elasticity measured with a non-invasive device, Skin Elastimeter
Measured: 8 weeks
Secondary outcomes (2)
Facial pigmentation
Facial pigment as measured by BTBP facial imaging analysis
Measured: 8 weeks
Facial redness
Facial pigment as measured by BTBP facial imaging analysis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start24 Jul 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- Model description
- Astaxanthin vs Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstaReal
- Responsible party
- Principal investigator, Raja Sivamani, MD MS AP, Integrative Skin Science and Research
- Investigators
- Raja Sivamani, MD, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882084
- Sponsor's protocol ID
- Asta_Skin_01
- Status last verified
- Jul 2023
- First submitted
- 21 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
- ClinicalTrials.gov ID
- NCT05882084
- Acronym / sponsor ID
- Asta_Skin_01
- Conditions
- Photoaging
- Keywords
- Carotenoid, Astaxanthin, Skin, Hydration, Elasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- AstaReal
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 May 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.
This study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Astaxanthin vs Placebo
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: Astaxanthin 6 mg daily6 mg daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females who are 30 to 55 years of age
- Half of the women will have Fitzpatrick skin type 1-3 and the other half of the women will have Fitzpatrick skin type 4-6
Key exclusion criteria (9 listed)
- Individuals with a known allergy to astaxanthin or other carotenoids (such as zeaxanthin, lutein, lycopene).
- Individuals who are unwilling to discontinue carotenoid supplementation for at least 1 month prior to enrollment
- Individuals unwilling to restrict intake of foods like shrimp, salmon, mangos, carrots, and tomatoes during the study.
- New supplementation within 4 weeks with tocopherol
- Individuals who are unwilling to stay consistent with a facial cleansing regimen.
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 |
|---|---|---|
| Astaxanthin 6 mg dailyAstaxanthin at 6 mg is given for daily ingestion and compared against placebo. | Dietary supplement | Astaxanthin |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Skin Hydration
Time frame: 8 weeks
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
Skin elasticity
Time frame: 8 weeks
Skin elasticity measured with a non-invasive device, Skin Elastimeter
2 secondary outcomes
Facial pigmentation
Time frame: 8 weeks
Facial redness
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- 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.
Raja Sivamani, MD principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin 6 mg daily in people with Photoaging, run by Integrative Skin Science and Research at 1 site in United States.
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 9 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 25 Jul 2023. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD (916-524-1216, research@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Hydration (time frame: 8 weeks). The study lists 2 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 25 Jul 2023.