Clinical trial NCT04872946: Topical and Oral Regimen for Skin Health
Official title: Topical and Oral Regimen for Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Abnormalities
Keywords: skin
dermatology
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Arbonne
First posted: 2021-05-05
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Changes in appearance of facial redness
timeFrame: 8 weeks
measure: Changes in appearance of facial pigmentation
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in appearance of facial redness before and after treatment
timeFrame: 8 weeks
measure: Subjective report of skin reactivity
timeFrame: 8 weeks
measure: Subjective report of sleep quality and quantity
timeFrame: 8 weeks
measure: Subjective report of mood and energy
timeFrame: 8 weeks
measure: Subjective report of calmness of mind
timeFrame: 8 weeks
measure: Subjective report of calmness of skin
timeFrame: 8 weeks
measure: Changes in appearance of facial redness
timeFrame: 4 weeks
measure: Changes in appearance of facial pigmentation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research Institute
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References: