Effect of Holy Basil on Subjects With Sensitive Skin
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Valencia, Valencia, Spain, 46019
- Recruiting
- Dermaclaim Lab S.L.
-
Contact:
- Dermaclaim Lab S.L.
- Phone Number: +34 961 87 45 82
- Email: dermaclaim@dermaclaim.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active product
Administration of HOLY BASIL
|
2 pills per day
|
|
Placebo Comparator: Placebo product
Administration of Placebo
|
2 pills per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitive skin symptoms
Time Frame: At baseline and after 28 days and 56 days
|
Evaluation using Sensitive Scale-10 (SS-10) questionnaire
|
At baseline and after 28 days and 56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived stress
Time Frame: At baseline and after 28 days and 56 days
|
Evaluation using PSS-10 questionnaire
|
At baseline and after 28 days and 56 days
|
|
Self perception
Time Frame: After 28 days and 56 days
|
Assessment using self assessment questionnaire
|
After 28 days and 56 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC.882.36.102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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