Topical and Oral Regimen for Skin Health

NCT04872946 | Completed

• 1 other identifier: 008
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Abnormalities

Keywords

skin; dermatology

Outcome Measures

Primary Outcomes (2)

• Changes in appearance of facial redness

  Photographic image analysis

  8 weeks

• Changes in appearance of facial pigmentation

  Photographic image analysis

  8 weeks

Secondary Outcomes (8)

• Changes in appearance of facial redness before and after treatment

  8 weeks

• Subjective report of skin reactivity

  8 weeks

• Subjective report of sleep quality and quantity

  8 weeks

• Subjective report of mood and energy

  8 weeks

• Subjective report of calmness of mind

  8 weeks

Study Arms (3)

InnerCalm+skin care

EXPERIMENTAL

An oral supplement and topical agent will be assigned.

Dietary Supplement: Tea; Other: Serum; Other: Moisturizer

InnerCalm only

EXPERIMENTAL

An oral supplement will be assigned.

Dietary Supplement: Tea

Skincare Only

EXPERIMENTAL

A topical agent only will be assigned.

Other: Serum; Other: Moisturizer

Interventions

Tea DIETARY_SUPPLEMENT

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

InnerCalm only; InnerCalm+skin care

Serum OTHER

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.

InnerCalm+skin care; Skincare Only

Moisturizer OTHER

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.

InnerCalm+skin care; Skincare Only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Arbonne: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Skin Abnormalities

Interventions

Tea

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Raja K Sivamani, MD

  Integrative Skin Science and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: May 5, 2021
• Study Start: November 26, 2019
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Locations

US (1)