Skin Abnormalities Clinical Trial
Official title:
Topical and Oral Regimen for Skin Health
NCT number | NCT04872946 |
Other study ID # | 008 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 26, 2019 |
Est. completion date | May 7, 2020 |
Verified date | April 2021 |
Source | Integrative Skin Science and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | May 7, 2020 |
Est. primary completion date | May 7, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Integrative Skin Science and Research | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Integrative Skin Science and Research | Arbonne |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in appearance of facial redness | Photographic image analysis | 8 weeks | |
Primary | Changes in appearance of facial pigmentation | Photographic image analysis | 8 weeks | |
Secondary | Changes in appearance of facial redness before and after treatment | SkinColorCatch colorimeter RGB range: 25-246 per channel | 8 weeks | |
Secondary | Subjective report of skin reactivity | Topical Clinical Questionnaire | 8 weeks | |
Secondary | Subjective report of sleep quality and quantity | Pittsburg Sleep Quality Index survey (PSQI) | 8 weeks | |
Secondary | Subjective report of mood and energy | Abbreviated Profile of Mood States Survey (POMS) | 8 weeks | |
Secondary | Subjective report of calmness of mind | Inner and Outer Calm Questionnaire | 8 weeks | |
Secondary | Subjective report of calmness of skin | Inner and Outer Calm Questionnaire | 8 weeks | |
Secondary | Changes in appearance of facial redness | Photographic image analysis | 4 weeks | |
Secondary | Changes in appearance of facial pigmentation | Photographic image analysis | 4 weeks |
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