Healthy VolunteersNCT06037291
Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin
A study testing Coriander Seed Oil in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
Trial summary
The study is aimed to assess the soothing effect of a food supplement composed of Coriander Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on sensitive and reactive skin. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Coriander Seed Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2021to 31 Jan 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health
- Caucasian ethnicity
- Female sex
- Phototype I to IV
- Sensitive and reactive skin (showing positive answer from 3-moderate to 4-strong to stinging test performed with a 10% lactic acid solution)
- Age between 18 and 65 years old (subject with 18 and 65 years old can be included)
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- Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement)
- Willingness to use during all the study period only the products to be tested
- Willingness not to use similar products that could interfere with the product to be tested
- Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.)
- Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial
- Subject aware of the study procedures and having signed an informed consent form
- Subjects who accept not to expose in intensive way to UV rays during the whole study duration
- Subjects who have not involved in any sun test (for SPF evaluation) or tests that provide skin irradiation since less than two months
Who cannot join
- Subject does not meet the inclusion criteria,
- Pregnant/breastfeeding female or who have planned a pregnancy during the study period
- Subjects under systemically pharmacological treatment
- Subjects under locally pharmacological treatment on the skin area monitored during the test
- Subjects with congenital or acquired immunodeficiency
- Subjects under treatment with food supplements which could interfere with the functionality of the product under study
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- Subjects which show skin alterations on the monitored area which could interfere with the functionality of the product under study
- Subjects considered as not adequate to participate to the study by the investigator
- Subjects with known or suspected sensitization to one or more test formulation ingredients
- Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated)
- Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.
The study is aimed to assess the soothing effect of a food supplement composed of Coriander Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on sensitive and reactive skin.
Read the detailed description
A double blind, parallel groups, placebo-controlled study is carried out on 80 female subjects aged between 18 and 65 years old with sensitive and reactive skin.
The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption.
- Conditions
- Healthy Volunteers
- Being tested
- Coriander Seed Oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriander Seed OilDietary supplement
The study foresees the intake of 1 capsule per day during 56 days
PlaceboDietary supplement
The study foresees the intake of 1 capsule per day during 56 days
| Study group | Role | What they receive |
|---|---|---|
| Coriander Seed Oil | Experimental | Dietary supplement - Coriander Seed Oil Receives: Dietary Supplement: Coriander Seed Oil |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Measured: Baseline
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Measured: 14 days
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Measured: 28 days
Skin redness
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Measured: 56 days
Secondary outcomes (9)
Skin stinging
Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
Measured: Baseline
Skin stinging
Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
Measured: 14 days
Skin stinging
Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
Measured: 28 days
Skin stinging
Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
Measured: 56 days
Erythema index
Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.
Measured: Baseline
Erythema index
Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.
Measured: 56 days
Skin TNF-alpha quantification (subgroup of 20 subjects)
Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
Measured: Baseline
Skin TNF-alpha quantification (subgroup of 20 subjects)
Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
Measured: 56 days
Self-assessment of product efficacy
Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Oct 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ileana De Ponti, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037291
- Sponsor's protocol ID
- IT0002762/21
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT06037291
- Acronym / sponsor ID
- IT0002762/21
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Sep 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.
The study is aimed to assess the soothing effect of a food supplement composed of Coriander Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on sensitive and reactive skin.
Detailed description
A double blind, parallel groups, placebo-controlled study is carried out on 80 female subjects aged between 18 and 65 years old with sensitive and reactive skin.
The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coriander Seed Oil | Experimental | Dietary Supplement: Coriander Seed OilDietary supplement - Coriander Seed Oil |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Good general health
- Caucasian ethnicity
- Female sex
- Phototype I to IV
- Sensitive and reactive skin (showing positive answer from 3-moderate to 4-strong to stinging test performed with a 10% lactic acid solution)
Key exclusion criteria (11 listed)
- Subject does not meet the inclusion criteria,
- Pregnant/breastfeeding female or who have planned a pregnancy during the study period
- Subjects under systemically pharmacological treatment
- Subjects under locally pharmacological treatment on the skin area monitored during the test
- Subjects with congenital or acquired immunodeficiency
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 |
|---|---|---|
| Coriander Seed OilThe study foresees the intake of 1 capsule per day during 56 days | Dietary supplement | Coriander Seed Oil |
| PlaceboThe study foresees the intake of 1 capsule per day during 56 days | Dietary supplement | Placebo |
Primary outcome
Skin redness
Time frame: Baseline
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Time frame: 14 days
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Time frame: 28 days
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
Skin redness
Time frame: 56 days
Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
9 secondary outcomes
Skin stinging
Time frame: Baseline
Skin stinging
Time frame: 14 days
Skin stinging
Time frame: 28 days
Skin stinging
Time frame: 56 days
Erythema index
Time frame: Baseline
Erythema index
Time frame: 56 days
Skin TNF-alpha quantification (subgroup of 20 subjects)
Time frame: Baseline
Skin TNF-alpha quantification (subgroup of 20 subjects)
Time frame: 56 days
Self-assessment of product efficacy
Time frame: 56 days
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 14 Sep 2023.
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Screening Protocol
Pain
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.
Ileana De Ponti study director
Complife Italia Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coriander Seed Oil in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
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 14 inclusion and 11 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 14 Sep 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 Italy. 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?
Skin redness (time frame: Baseline). The study lists 4 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 14 Sep 2023.