Topical and Oral Regimen for Skin Health
- Conditions
- Skin Abnormalities
- Interventions
- Dietary Supplement: TeaOther: SerumOther: Moisturizer
- Registration Number
- NCT04872946
- Lead Sponsor
- Integrative Skin Science and Research
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 74
- Women aged 18-55
- Fitzpatrick skin type 1-4
- Self-perception as sensitive skin
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description InnerCalm+skin care Serum An oral supplement and topical agent will be assigned. InnerCalm only Tea An oral supplement will be assigned. Skincare Only Moisturizer A topical agent only will be assigned. Skincare Only Serum A topical agent only will be assigned. InnerCalm+skin care Tea An oral supplement and topical agent will be assigned. InnerCalm+skin care Moisturizer An oral supplement and topical agent will be assigned.
- Primary Outcome Measures
Name Time Method Changes in appearance of facial redness 8 weeks Photographic image analysis
Changes in appearance of facial pigmentation 8 weeks Photographic image analysis
- Secondary Outcome Measures
Name Time Method Subjective report of calmness of skin 8 weeks Inner and Outer Calm Questionnaire
Changes in appearance of facial redness 4 weeks Photographic image analysis
Subjective report of mood and energy 8 weeks Abbreviated Profile of Mood States Survey (POMS)
Changes in appearance of facial pigmentation 4 weeks Photographic image analysis
Changes in appearance of facial redness before and after treatment 8 weeks SkinColorCatch colorimeter RGB range: 25-246 per channel
Subjective report of skin reactivity 8 weeks Topical Clinical Questionnaire
Subjective report of sleep quality and quantity 8 weeks Pittsburg Sleep Quality Index survey (PSQI)
Subjective report of calmness of mind 8 weeks Inner and Outer Calm Questionnaire
Trial Locations
- Locations (1)
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States