Effect of Holy Basil on Subjects With Sensitive Skin

NCT07811310 | Recruiting

• 1 other identifier: DC.882.36.102
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensitive Skin Related to Stress

Outcome Measures

Primary Outcomes (1)

• Sensitive skin symptoms

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

  At baseline and after 28 days and 56 days

Secondary Outcomes (2)

• Perceived stress

  At baseline and after 28 days and 56 days

• Self perception

  After 28 days and 56 days

Study Arms (2)

Active product

ACTIVE COMPARATOR

Administration of HOLY BASIL

Dietary Supplement: Holy basil extract

Placebo product

PLACEBO COMPARATOR

Administration of Placebo

Dietary Supplement: Placebo

Interventions

Holy basil extract DIETARY_SUPPLEMENT

2 pills per day

Active product

Placebo DIETARY_SUPPLEMENT

2 pills per day

Placebo product

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires Expanscience S.A.: lead
• Dermaclaim Lab S.L.: collaborator

Study Sites (1)

Dermaclaim Lab S.L.

Valencia, Valencia, 46019, Spain

RECRUITING

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 22969795 BACKGROUND

• 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.

  PMID: 34631261 BACKGROUND

• 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.

  PMID: 17108900 BACKGROUND

MeSH Terms

Interventions

holy basil leaf extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

ES (1)