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Topical and Oral Regimen for Skin Health

Primary Purpose

Skin Abnormalities

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tea
Serum
Moisturizer
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Abnormalities focused on measuring skin, dermatology

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Integrative Skin Science and Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

InnerCalm+skin care

InnerCalm only

Skincare Only

Arm Description

An oral supplement and topical agent will be assigned.

An oral supplement will be assigned.

A topical agent only will be assigned.

Outcomes

Primary Outcome Measures

Changes in appearance of facial redness
Photographic image analysis
Changes in appearance of facial pigmentation
Photographic image analysis

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2020
Last Updated
April 29, 2021
Sponsor
Integrative Skin Science and Research
Collaborators
Arbonne
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1. Study Identification

Unique Protocol Identification Number
NCT04872946
Brief Title
Topical and Oral Regimen for Skin Health
Official Title
Topical and Oral Regimen for Skin Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Arbonne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abnormalities
Keywords
skin, dermatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InnerCalm+skin care
Arm Type
Experimental
Arm Description
An oral supplement and topical agent will be assigned.
Arm Title
InnerCalm only
Arm Type
Experimental
Arm Description
An oral supplement will be assigned.
Arm Title
Skincare Only
Arm Type
Experimental
Arm Description
A topical agent only will be assigned.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tea
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Serum
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moisturizer
Intervention Description
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 Outcome Measure Information:
Title
Changes in appearance of facial redness
Description
Photographic image analysis
Time Frame
8 weeks
Title
Changes in appearance of facial pigmentation
Description
Photographic image analysis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in appearance of facial redness before and after treatment
Description
SkinColorCatch colorimeter RGB range: 25-246 per channel
Time Frame
8 weeks
Title
Subjective report of skin reactivity
Description
Topical Clinical Questionnaire
Time Frame
8 weeks
Title
Subjective report of sleep quality and quantity
Description
Pittsburg Sleep Quality Index survey (PSQI)
Time Frame
8 weeks
Title
Subjective report of mood and energy
Description
Abbreviated Profile of Mood States Survey (POMS)
Time Frame
8 weeks
Title
Subjective report of calmness of mind
Description
Inner and Outer Calm Questionnaire
Time Frame
8 weeks
Title
Subjective report of calmness of skin
Description
Inner and Outer Calm Questionnaire
Time Frame
8 weeks
Title
Changes in appearance of facial redness
Description
Photographic image analysis
Time Frame
4 weeks
Title
Changes in appearance of facial pigmentation
Description
Photographic image analysis
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, MD
Organizational Affiliation
Integrative Skin Science and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States

12. IPD Sharing Statement

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Topical and Oral Regimen for Skin Health

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