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Topical and Oral Regimen for Skin Health

Topical and Oral Regimen for Skin Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04872946
Enrollment
74
Registered
2021-05-05
Start date
2019-11-26
Completion date
2020-05-07
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Abnormalities

Keywords

skin, dermatology

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.

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).

Interventions

DIETARY_SUPPLEMENTTea

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

OTHERSerum

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.

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.

Sponsors

Arbonne
CollaboratorUNKNOWN
Integrative Skin Science and Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in appearance of facial redness8 weeksPhotographic image analysis
Changes in appearance of facial pigmentation8 weeksPhotographic image analysis

Secondary

MeasureTime frameDescription
Subjective report of sleep quality and quantity8 weeksPittsburg Sleep Quality Index survey (PSQI)
Subjective report of mood and energy8 weeksAbbreviated Profile of Mood States Survey (POMS)
Subjective report of calmness of mind8 weeksInner and Outer Calm Questionnaire
Changes in appearance of facial redness before and after treatment8 weeksSkinColorCatch colorimeter RGB range: 25-246 per channel
Changes in appearance of facial redness4 weeksPhotographic image analysis
Changes in appearance of facial pigmentation4 weeksPhotographic image analysis
Subjective report of calmness of skin8 weeksInner and Outer Calm Questionnaire
Subjective report of skin reactivity8 weeksTopical Clinical Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026