Topical and Oral Regimen for Skin Health

Integrative Skin Science and Research

Status: Completed

Conditions: Skin Abnormalities

Treatments: Other: Serum; Other: Moisturizer; Dietary Supplement: Tea

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04872946

008

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 3 patient groups

InnerCalm+skin care

Experimental group

Description:

An oral supplement and topical agent will be assigned.

Treatment:

Other: Moisturizer

Dietary Supplement: Tea

Other: Serum

InnerCalm only

Experimental group

Description:

An oral supplement will be assigned.

Treatment:

Dietary Supplement: Tea

Skincare Only

Experimental group

Description:

A topical agent only will be assigned.

Treatment:

Other: Moisturizer

Other: Serum