Topical and Oral Regimen for Skin Health

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.

Study Overview

• Status: Completed
• Conditions: Skin Abnormalities
• Intervention / Treatment: Dietary supplement: Tea; Other: Serum; Other: Moisturizer

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InnerCalm+skin care; An oral supplement and topical agent will be assigned.	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.; Other: 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.
Experimental: InnerCalm only; An oral supplement will be assigned.	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
Experimental: Skincare Only; A topical agent only will be assigned.	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in appearance of facial redness	Photographic image analysis	8 weeks
Changes in appearance of facial pigmentation	Photographic image analysis	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Arbonne
• Investigators: Principal Investigator: Raja K Sivamani, MD, Integrative Skin Science and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: skin; dermatology
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Skin Abnormalities
• Other Study ID Numbers: 008 (Nahrain Medical Research Collective (NMRC))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No