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CompletedNCT04872946Updated May 5, 2021

Topical and Oral Regimen for Skin Health

An interventional study of Tea and Serum in Skin Abnormalities, sponsored by Integrative Skin Science and Research. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-05-05.

Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2019, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Skin Abnormalities

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Keywords

  • skin
  • dermatology
03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's enrollment of 74 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.

Browse Integrative Skin Science and Research studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    InnerCalm+skin care

    An oral supplement and topical agent will be assigned.

    Dietary Supplement: Tea · Other: Serum · Other: Moisturizer

  • Experimental
    InnerCalm only

    An oral supplement will be assigned.

    Dietary Supplement: Tea

  • Experimental
    Skincare Only

    A topical agent only will be assigned.

    Other: Serum · Other: Moisturizer

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.

  • OtherMoisturizer

    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.

06

What researchers measure

Primary outcomes

  1. Changes in appearance of facial redness

    Photographic image analysis

    Time frame: 8 weeks

  2. Changes in appearance of facial pigmentation

    Photographic image analysis

    Time frame: 8 weeks

Secondary outcomes

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

    SkinColorCatch colorimeter RGB range: 25-246 per channel

    Time frame: 8 weeks

  2. Subjective report of skin reactivity

    Topical Clinical Questionnaire

    Time frame: 8 weeks

  3. Subjective report of sleep quality and quantity

    Pittsburg Sleep Quality Index survey (PSQI)

    Time frame: 8 weeks

  4. Subjective report of mood and energy

    Abbreviated Profile of Mood States Survey (POMS)

    Time frame: 8 weeks

  5. Subjective report of calmness of mind

    Inner and Outer Calm Questionnaire

    Time frame: 8 weeks

  6. Subjective report of calmness of skin

    Inner and Outer Calm Questionnaire

    Time frame: 8 weeks

  7. Changes in appearance of facial redness

    Photographic image analysis

    Time frame: 4 weeks

  8. Changes in appearance of facial pigmentation

    Photographic image analysis

    Time frame: 4 weeks

07

Study locations

1 site
  • Integrative Skin Science and Research
    Sacramento, California 95815, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in May 2020, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2020
First posted
May 5, 2021
StartActual
Nov 26, 2019
Primary completionActual
May 7, 2020
CompletionActual
May 7, 2020
Last update
May 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04872946
Lead sponsor
Integrative Skin Science and Research
Collaborators
Arbonne
Responsible party
Sponsor
First posted
May 5, 2021
Start date
Nov 26, 2019
Primary completion
May 7, 2020
Completion
May 7, 2020
Last update
May 5, 2021

Study contacts

Raja K Sivamani, MD
principal investigator · Integrative Skin Science and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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