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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05271487
Recruitment Status : Not yet recruiting
First Posted : March 9, 2022
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Codex Beauty Corporation
Information provided by (Responsible Party):
Raja Sivamani, MD MS AP, Integrative Skin Science and Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Multi-Step Botanical Skin Care Regimen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
Estimated Study Start Date : March 7, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: Multi-Step Botanical Skin Care Regimen
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

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


Outcome Measures
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Primary Outcome Measures :
  1. Total lesion count [ Time Frame: 8 weeks ]
    Number of of inflammatory lesions, and open and closed comedones


Secondary Outcome Measures :
  1. Inflammatory lesion count [ Time Frame: 4 weeks ]
    Number of inflammatory lesions

  2. Inflammatory lesion count [ Time Frame: 8 weeks ]
    Number of inflammatory lesions

  3. Non-inflammatory lesion count [ Time Frame: 4 weeks ]
    Number of open and closed comedones

  4. Non-inflammatory lesion count [ Time Frame: 8 weeks ]
    Number of open and closed comedones

  5. Investigator global assessment (IGA) of acne [ Time Frame: 4 weeks ]
    Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne

  6. Investigator global assessment (IGA) of acne [ Time Frame: 8 weeks ]
    Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne

  7. Sebum excretion [ Time Frame: 4 weeks ]
    Measure of skin sebum via sebumeter

  8. Sebum excretion [ Time Frame: 8 weeks ]
    Measure of skin sebum via sebumeter

  9. Gut microbiome assessment [ Time Frame: 4 weeks ]
    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  10. Gut microbiome assessment [ Time Frame: 8 weeks ]
    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

  11. Skin microbiome diversity [ Time Frame: 4 weeks ]
    Shift in Shannon diversity of the skin microbiome

  12. Skin microbiome diversity [ Time Frame: 8 weeks ]
    Shift in Shannon diversity of the skin microbiome

  13. Positive and Negative Affect Schedule (PANAS-SF) [ Time Frame: 4 weeks ]
    Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect

  14. Positive and Negative Affect Schedule (PANAS-SF) [ Time Frame: 8 weeks ]
    Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect

  15. Diurnal Cortisol Slope [ Time Frame: 4 weeks ]
    4 salivary cortisol collections to assess diurnal slope

  16. Diurnal Cortisol Slope [ Time Frame: 8 weeks ]
    4 salivary cortisol collections to assess diurnal slope

  17. Salivary Sex Hormone Levels [ Time Frame: 4 weeks ]
    1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS

  18. Salivary Sex Hormone Levels [ Time Frame: 8 weeks ]
    1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05271487


Contacts
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Contact: Jessica Maloh 9167502463 jessica@integrativeskinresearch.com

Locations
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United States, California
Integrative Skin Science and Research
Sacramento, California, United States, 95819
Contact: Jessica Maloh    916-750-2463    jessica@integrativeskinresearch.com   
Principal Investigator: Raja Sivamani, MD MS AP         
Sponsors and Collaborators
Integrative Skin Science and Research
Codex Beauty Corporation
More Information
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Responsible Party: Raja Sivamani, MD MS AP, Principal Investigator, Integrative Skin Science and Research
ClinicalTrials.gov Identifier: NCT05271487    
Other Study ID Numbers: CB_Acne_01
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raja Sivamani, MD MS AP, Integrative Skin Science and Research:
botanical
microbiome
skin care
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases