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Completed

NCT Number: NCT04872946

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Changes in appearance of facial redness

    Time frame: 8 weeks

    Photographic image analysis

  2. Changes in appearance of facial pigmentation

    Time frame: 8 weeks

    Photographic image analysis

Secondary outcomes

  1. Changes in appearance of facial redness before and after treatment

    Time frame: 8 weeks

    SkinColorCatch colorimeter RGB range: 25-246 per channel

  2. Subjective report of skin reactivity

    Time frame: 8 weeks

    Topical Clinical Questionnaire

  3. Subjective report of sleep quality and quantity

    Time frame: 8 weeks

    Pittsburg Sleep Quality Index survey (PSQI)

  4. Subjective report of mood and energy

    Time frame: 8 weeks

    Abbreviated Profile of Mood States Survey (POMS)

  5. Subjective report of calmness of mind

    Time frame: 8 weeks

    Inner and Outer Calm Questionnaire

  6. Subjective report of calmness of skin

    Time frame: 8 weeks

    Inner and Outer Calm Questionnaire

  7. Changes in appearance of facial redness

    Time frame: 4 weeks

    Photographic image analysis

  8. Changes in appearance of facial pigmentation

    Time frame: 4 weeks

    Photographic image analysis

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Arbonne

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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