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RecruitingNCT07811310Updated Sep 10, 2026

Effect of Holy Basil on Subjects With Sensitive Skin

An interventional study of Holy basil extract and Placebo in Sensitive Skin Related to Stress, sponsored by Laboratoires Expanscience S.A.. Recruiting at 1 site in Spain. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Laboratoires Expanscience S.A. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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 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.

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Conditions studied

  • Sensitive Skin Related to Stress
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In context

Lead sponsor

Laboratoires Expanscience S.A. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
  • People with allergies to 'purple basil' or its (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Active product

    Administration of HOLY BASIL

    Dietary Supplement: Holy basil extract

  • Placebo comparator
    Placebo product

    Administration of Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementHoly basil extract

    2 pills per day

  • Dietary supplementPlacebo

    2 pills per day

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What researchers measure

Primary outcomes

  1. Sensitive skin symptoms

    Evaluation using Sensitive Scale-10 (SS-10) questionnaire

    Time frame: At baseline and after 28 days and 56 days

Secondary outcomes

  1. Perceived stress

    Evaluation using PSS-10 questionnaire

    Time frame: At baseline and after 28 days and 56 days

  2. Self perception

    Assessment using self assessment questionnaire

    Time frame: After 28 days and 56 days

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Study locations

1 of 1 sites recruiting
  • Dermaclaim Lab S.L.
    Valencia, Valencia 46019, Spain
    Recruiting
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References and documents

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 22969795 ↗
  • Graubard 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 34631261 ↗
  • Colavincenzo 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07811310
Lead sponsor
Laboratoires Expanscience S.A.
Collaborators
Dermaclaim Lab S.L.
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Aug 31, 2026
Primary completion
Nov 18, 2026 (estimated)
Completion
Nov 18, 2026 (estimated)
Last update
Sep 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Holy basil leaf extract

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