A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

NCT05271487 | Unknown

• 1 other identifier: CB_Acne_01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.

Conditions

Acne Vulgaris

Keywords

botanical; microbiome; skin care

Outcome Measures

Primary Outcomes (1)

• Total lesion count

  Number of of inflammatory lesions, and open and closed comedones

  8 weeks

Secondary Outcomes (18)

• Inflammatory lesion count

  4 weeks

• Inflammatory lesion count

  8 weeks

• Non-inflammatory lesion count

  4 weeks

• Non-inflammatory lesion count

  8 weeks

• Investigator global assessment (IGA) of acne

  4 weeks

Study Arms (1)

Multi-Step Botanical Skin Care Regimen

EXPERIMENTAL

The patient will be provided with and instructed to use a cleanser, toner, oil control cream, exfoliating facial scrub, clay mask, acne spot treatment, and body scrub for the duration of the study.

Other: Multi-Step Botanical Skin Care Regimen

Interventions

Multi-Step Botanical Skin Care Regimen OTHER

The intervention includes 7 different topical products: 1. Cleanser 2. Toner 3. Oil Control Cream 4. Exfoliating Facial Scrub 5. Clay Mask 6. Acne Spot Treatment 7. Body Scrub

Multi-Step Botanical Skin Care Regimen

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects 15 years of age until 45 years of age.
• The presence of mild to moderate acne based on investigator global assessment.

You may not qualify if:

• The presence of severe acne as noted by the investigator global assessment.
• Those with a nut allergy.
• Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
• Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
• Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
• Individuals who have been on an oral antibiotic for acne within the previous 1 month.
• Individuals who are pregnant or breastfeeding.
• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
• Oral supplementation that has nuts in it.
• Use of isotretinoin within the three months prior to joining the study.
• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Codex Beauty Corporation: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95819, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Jessica Maloh

CONTACT

9167502463; jessica@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 9, 2022
• Study Start: March 7, 2022
• Primary Completion: July 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)