Topical and Oral Regimen for Skin Health

Skin Abnormalities Clinical Trial

Official title:

Topical and Oral Regimen for Skin Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872946
• Other study ID #: 008
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: May 7, 2020

Study information

• Verified date: April 2021
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to assess how oral supplementation with Inner Calm and the use of topical Super Calm can affect the appearance of skin and inner wellness, such as redness, skin sensitivity, and reactionary skin.

Description:

The landscape for skin health has expanded past a focused use of topicals to incorporate the use of supplementation. Notable examples include the ingestion of carotenoids and beta-carotene to augment skin antioxidant status or the role of diet on different skin conditions. The role of this investigation is to define how Inner Calm (oral supplementation) may promote healthier skin and how this may work in synergy with Super Calm (topical supplementation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women aged 18-55
• Fitzpatrick skin type 1-4
• Self-perception as sensitive skin Exclusion Criteria:

Exclusion Criteria:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant or breast-feeding women
• Prisoners
• Those who have used isotretinoin in the last 6 months
• Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E or topical retinoids or topical depigmenting agents (such as hydroquinone, kojic acid, azelaic acid, or others in opinion of the investigator) in the last 14 days
• Those who are currently smoking or have smoked within the past 3 years.
• Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles, redness, or hyperpigmentation, such as botulinum toxin injections, chemical peels, laser-based therapies to the face, or face lift surgeries
• Subjects with known allergy to any of the components of Inner Calm or Skin Calm
• Those that are unwilling to discontinue use of any other nutritional supplements including antioxidants, herbs, or protein-based supplements for 2 weeks prior to and during their participation.
• Subjects with a diagnosis of acne

Related Conditions & MeSH terms

• Skin Abnormalities

Intervention

Dietary Supplement:
• Tea
Ashwagandha(Withania somnifera) root and leaf extract (32% Withania Oligosaccharides, 10% Withanolide Glycosides, 0.5% Withaferin A) 125 mg Saffron(Crocus Sativus) stigmas extract (3.48% Crocin and 0.03% Safranal) 28mg

Other:
• Serum
Aqua/Water/Eau, Glycerin, Propanediol, Diheptyl Succinate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Sorbitol, Dimethicone, Steareth-21, Octyldodecyl Neopentanoate, Sodium Polyacrylate, Steareth-2, Caprylyl Glycol, Hydrogenated Polydecene, Trideceth-6, Octyldodecanol, Panthenol, Sodium PCA, Azelaic Acid, Bisabolol, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Caprylhydroxamic Acid, Phytic Acid, Aminomethyl Propanol, Lactic Acid, Sodium Chloride, Phenoxyethanol, Sodium Benzoate.
• Moisturizer
Aqua/Water/Eau, Glycerin, Diisopropyl Dimer Dilinoleate, Coco-Caprylate, Lactococcus Ferment Lysate, Myristyl Myristate, Dimethicone, Propanediol, Behenyl Alcohol, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Palmitic Acid, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Myristyl Laurate, Caprylyl Glycol, Hydroxyethylcellulose, Myristic Acid, Tocopherol, Ethylhexylglycerin, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Helianthus Annuus (Sunflower) Seed Oil, Trisodium Ethylenediamine Disuccinate, Lactic Acid, Sodium Hydroxide, Sodium Phosphate, Disodium Phosphate, Sodium Chloride, t-Butyl Alcohol, Phenoxyethanol, Sodium Benzoate.

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Arbonne

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in appearance of facial redness	Photographic image analysis	8 weeks
Primary	Changes in appearance of facial pigmentation	Photographic image analysis	8 weeks
Secondary	Changes in appearance of facial redness before and after treatment	SkinColorCatch colorimeter RGB range: 25-246 per channel	8 weeks
Secondary	Subjective report of skin reactivity	Topical Clinical Questionnaire	8 weeks
Secondary	Subjective report of sleep quality and quantity	Pittsburg Sleep Quality Index survey (PSQI)	8 weeks
Secondary	Subjective report of mood and energy	Abbreviated Profile of Mood States Survey (POMS)	8 weeks
Secondary	Subjective report of calmness of mind	Inner and Outer Calm Questionnaire	8 weeks
Secondary	Subjective report of calmness of skin	Inner and Outer Calm Questionnaire	8 weeks
Secondary	Changes in appearance of facial redness	Photographic image analysis	4 weeks
Secondary	Changes in appearance of facial pigmentation	Photographic image analysis	4 weeks