Sensitive Skin Related to StressNCT07811310
Effect of Holy Basil on Subjects With Sensitive Skin
A study testing Holy basil extract in people with Sensitive Skin Related to Stress, run by Laboratoires Expanscience S.A. at 1 site in Spain.
Trial summary
Stress can have multiple and varied psychological and clinical impacts on skin diseases (Colavincenzo and Granstein, 2006; Graubard et al., 2021). In particular, psychological stress has been shown to reduce the rebuilding kinetics of the skin barrier when altered and it is suggested that psychological stress may… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin Related to Stress
- What is being tested?
- Holy basil extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2026to 18 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: Women
- People aged between 45 and 65 years.
- Presenting sensitive skin (Sensitive Scale 10 ≥ 20) with Tightness ≥ 4 and general malaise ≥ 4.
- People who report being stressed (PSS10 questionnaire ≥ 14) and who report a relationship between skin sensitivity and psychological stress (according to the volunteer's opinion).
- Last participation in a clinical study on the face, which ended at least 8 weeks before the start of this study.
- Washing phase of 15 days without application of products on the face, or oral intake.
Who cannot join
- People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- People with allergies to 'purple basil' or its excipients (maltodextrin, magnesium stearate).
- Have other physiological disorders (diabetes, hypertension, dyslipidemia) and/or gallstones.
- Individuals under medical treatment in the weeks prior to the study, which may interfere with the evaluations of the present study.
- People who are pregnant or intend to be pregnant within the study period, as well as people who are breastfeeding.
- People who are within a dietary period outside of their usual habit, or intend to change their eating routine during the study period.
- People participating in another clinical study with similar characteristics (according to the investigator's criteria), during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Dermaclaim Lab S.L.
Valencia, Valencia, 46019
Dermaclaim Lab S.L., +34 961 87 45 82, dermaclaim@dermaclaim.com
About this study
Official title: OBSERVATIONAL STUDY OF THE EFFICACY ON SENSITIVE SKIN OF AN ORAL FORMULATION BASED ON PURPLE BASIL, FOR 8 WEEKS IN 2 GROUPS OF 100 VOLUNTEERS
Stress can have multiple and varied psychological and clinical impacts on skin diseases (Colavincenzo and Granstein, 2006; Graubard et al., 2021). In particular, psychological stress has been shown to reduce the rebuilding kinetics of the skin barrier when altered and it is suggested that psychological stress may trigger or exacerbate immune-mediated dermatological disorders (Hall et al., 2012). Certain symptoms related to sensitive skin problems (itching, burning, pain, etc.) can lead to sleep disorders associated with stress and anxiety. Conversely, these sleep disorders and anxiety or stress due to external sources are known to promote the appearance of symptoms related to skin sensitivity in patients who are at risk of developing sensitive skin syndrome (Farage, 2022).
Expanscience Laboratories, manufacturer of cosmetics and dietary supplements, has identified a HOLY BASIL plant extract as a solution to address the negative impacts of stress on sensitive skin symptoms.
The main goal of this double blinded randomized controlled clinical study is to evaluate in vivo the effect of an active ingredient HOLY BASIL incorporated into a food supplement on sensitive skin symptoms related to psychological stress after 28 and 56 consecutive days of a twice-daily intake, in comparison with the baseline and a placebo. Evaluation of the effectiveness of HOLY BASIL will be evaluated using psychometric questionnaires related to stress, sensitive skin and overall perception.
- Conditions
- Sensitive Skin Related to Stress
- Being tested
- Holy basil extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holy basil extractDietary supplement
2 pills per day
PlaceboDietary supplement
2 pills per day
| Study group | Role | What they receive |
|---|---|---|
| Active product | Active comparator | Administration of HOLY BASIL Receives: Dietary Supplement: Holy basil extract |
| Placebo product | Placebo comparator | Administration of Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitive skin symptoms
Evaluation using Sensitive Scale-10 (SS-10) questionnaire
Measured: At baseline and after 28 days and 56 days
Secondary outcomes (2)
Perceived stress
Evaluation using PSS-10 questionnaire
Measured: At baseline and after 28 days and 56 days
Self perception
Assessment using self assessment questionnaire
Measured: After 28 days and 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Aug 2026
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sensitive Skin Related to StressStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Expanscience S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermaclaim Lab S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811310
- Sponsor's protocol ID
- DC.882.36.102
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farage, M. A. (2022). Psychological Aspects of Sensitive Skin: A Vicious Cycle. Cosmetics 2022, Vol. 9, Page 78, 9(4), 78. https://doi.org/10.3390/COSMETICS9040078
Hall JM, Cruser D, Podawiltz A, Mummert DI, Jones H, Mummert ME. Psychological Stress and the Cutaneous Immune Response: Roles of the HPA Axis and the Sympathetic Nervous System in Atopic Dermatitis and Psoriasis. Dermatol Res Pract. 2012;2012:403908. doi: 10.1155/2012/403908. Epub 2012 Aug 30.
PubMed 22969795Graubard R, Perez-Sanchez A, Katta R. Stress and Skin: An Overview of Mind Body Therapies as a Treatment Strategy in Dermatology. Dermatol Pract Concept. 2021 Sep 1;11(4):e2021091. doi: 10.5826/dpc.1104a91. eCollection 2021 Sep.
PubMed 34631261Colavincenzo ML, Granstein RD. Stress and the skin: a meeting report of the Weill Cornell Symposium on the Science of Dermatology. J Invest Dermatol. 2006 Dec;126(12):2560-1. doi: 10.1038/sj.jid.5700565. No abstract available.
PubMed 17108900
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL STUDY OF THE EFFICACY ON SENSITIVE SKIN OF AN ORAL FORMULATION BASED ON PURPLE BASIL, FOR 8 WEEKS IN 2 GROUPS OF 100 VOLUNTEERS
- ClinicalTrials.gov ID
- NCT07811310
- Acronym / sponsor ID
- DC.882.36.102
- Conditions
- Sensitive Skin Related to Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laboratoires Expanscience S.A.Industry (pharma, biotech, devices)
- Collaborators
- Dermaclaim Lab S.L.
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 10 Sep 2026 (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.
Stress can have multiple and varied psychological and clinical impacts on skin diseases (Colavincenzo and Granstein, 2006; Graubard et al., 2021). In particular, psychological stress has been shown to reduce the rebuilding kinetics of the skin barrier when altered and it is suggested that psychological stress may trigger or exacerbate immune-mediated dermatological disorders (Hall et al., 2012). Certain symptoms related to sensitive skin problems (itching, burning, pain, etc.) can lead to sleep disorders associated with stress and anxiety. Conversely, these sleep disorders and anxiety or stress due to external sources are known to promote the appearance of symptoms related to skin sensitivity in patients who are at risk of developing sensitive skin syndrome (Farage, 2022).
Expanscience Laboratories, manufacturer of cosmetics and dietary supplements, has identified a HOLY BASIL plant extract as a solution to address the negative impacts of stress on sensitive skin symptoms.
The main goal of this double blinded randomized controlled clinical study is to evaluate in vivo the effect of an active ingredient HOLY BASIL incorporated into a food supplement on sensitive skin symptoms related to psychological stress after 28 and 56 consecutive days of a twice-daily intake, in comparison with the baseline and a placebo. Evaluation of the effectiveness of HOLY BASIL will be evaluated using psychometric questionnaires related to stress, sensitive skin and overall perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product | Active comparator | Dietary Supplement: Holy basil extractAdministration of HOLY BASIL |
| Placebo product | Placebo comparator | Dietary Supplement: PlaceboAdministration of Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender: Women
- People aged between 45 and 65 years.
- Presenting sensitive skin (Sensitive Scale 10 ≥ 20) with Tightness ≥ 4 and general malaise ≥ 4.
- People who report being stressed (PSS10 questionnaire ≥ 14) and who report a relationship between skin sensitivity and psychological stress (according to the volunteer's opinion).
- Last participation in a clinical study on the face, which ended at least 8 weeks before the start of this study.
Key exclusion criteria (7 listed)
- People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- People with allergies to 'purple basil' or its excipients (maltodextrin, magnesium stearate).
- Have other physiological disorders (diabetes, hypertension, dyslipidemia) and/or gallstones.
- Individuals under medical treatment in the weeks prior to the study, which may interfere with the evaluations of the present study.
- People who are pregnant or intend to be pregnant within the study period, as well as people who are breastfeeding.
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 |
|---|---|---|
| Holy basil extract2 pills per day | Dietary supplement | Active product |
| Placebo2 pills per day | Dietary supplement | Placebo product |
Primary outcome
Sensitive skin symptoms
Time frame: At baseline and after 28 days and 56 days
Evaluation using Sensitive Scale-10 (SS-10) questionnaire
2 secondary outcomes
Perceived stress
Time frame: At baseline and after 28 days and 56 days
Self perception
Time frame: After 28 days and 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- BackgroundFarage, M. A. (2022). Psychological Aspects of Sensitive Skin: A Vicious Cycle. Cosmetics 2022, Vol. 9, Page 78, 9(4), 78. https://doi.org/10.3390/COSMETICS9040078
- Background: PubMed 22969795Hall JM, Cruser D, Podawiltz A, Mummert DI, Jones H, Mummert ME. Psychological Stress and the Cutaneous Immune Response: Roles of the HPA Axis and the Sympathetic Nervous System in Atopic Dermatitis and Psoriasis. Dermatol Res Pract. 2012;2012:403908. doi: 10.1155/2012/403908. Epub 2012 Aug 30.
- Background: PubMed 34631261Graubard R, Perez-Sanchez A, Katta R. Stress and Skin: An Overview of Mind Body Therapies as a Treatment Strategy in Dermatology. Dermatol Pract Concept. 2021 Sep 1;11(4):e2021091. doi: 10.5826/dpc.1104a91. eCollection 2021 Sep.
- Background: PubMed 17108900Colavincenzo ML, Granstein RD. Stress and the skin: a meeting report of the Weill Cornell Symposium on the Science of Dermatology. J Invest Dermatol. 2006 Dec;126(12):2560-1. doi: 10.1038/sj.jid.5700565. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holy basil extract in people with Sensitive Skin Related to Stress, run by Laboratoires Expanscience S.A. at 1 site in Spain.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitive skin symptoms (time frame: At baseline and after 28 days and 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07811310, which also lists 4 linked publications.
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 10 Sep 2026.