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

• Sponsor: Integrative Skin Science and Research (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05271487
• Collaborator: Codex Beauty Corporation (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Mar 7, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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: Cleanser Toner Oil Control Cream Exfoliating Facial Scrub Clay Mask Acne Spot Treatment Body Scrub

Outcome Measures

Primary Outcome Measures

1. Total lesion count [8 weeks]

   Number of of inflammatory lesions, and open and closed comedones

Secondary Outcome Measures

1. Inflammatory lesion count [4 weeks]

   Number of inflammatory lesions

2. Inflammatory lesion count [8 weeks]

   Number of inflammatory lesions

3. Non-inflammatory lesion count [4 weeks]

   Number of open and closed comedones

4. Non-inflammatory lesion count [8 weeks]

   Number of open and closed comedones

5. Investigator global assessment (IGA) of acne [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 [8 weeks]

   Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne

7. Sebum excretion [4 weeks]

   Measure of skin sebum via sebumeter

8. Sebum excretion [8 weeks]

   Measure of skin sebum via sebumeter

9. Gut microbiome assessment [4 weeks]

   Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

10. Gut microbiome assessment [8 weeks]

    Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample

11. Skin microbiome diversity [4 weeks]

    Shift in Shannon diversity of the skin microbiome

12. Skin microbiome diversity [8 weeks]

    Shift in Shannon diversity of the skin microbiome

13. Positive and Negative Affect Schedule (PANAS-SF) [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) [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 [4 weeks]

    4 salivary cortisol collections to assess diurnal slope

16. Diurnal Cortisol Slope [8 weeks]

    4 salivary cortisol collections to assess diurnal slope

17. Salivary Sex Hormone Levels [4 weeks]

    1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS

18. Salivary Sex Hormone Levels [8 weeks]

    1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Integrative Skin Science and Research	Sacramento	California	United States	95819

Sponsors and Collaborators

• Integrative Skin Science and Research
• Codex Beauty Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Mar 9, 2022
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Principal Investigator, Integrative Skin Science and Research: botanical; microbiome; skin care
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Mar 9, 2022