Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05271487
NCT05271487
Unknown
Not Applicable

The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

Integrative Skin Science and Research1 site in 1 country20 target enrollmentMarch 7, 2022
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAcne Vulgaris

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acne Vulgaris
Sponsor
Integrative Skin Science and Research
Enrollment
20
Locations
1
Primary Endpoint
Total lesion count
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2022
End Date
March 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raja Sivamani, MD MS AP

Principal Investigator

Integrative Skin Science and Research

Eligibility 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.

Outcomes

Primary Outcomes

Total lesion count

Time Frame: 8 weeks

Number of of inflammatory lesions, and open and closed comedones

Secondary Outcomes

  • Sebum excretion(8 weeks)
  • Investigator global assessment (IGA) of acne(8 weeks)
  • Gut microbiome assessment(8 weeks)
  • Inflammatory lesion count(8 weeks)
  • Non-inflammatory lesion count(8 weeks)
  • Skin microbiome diversity(8 weeks)
  • Positive and Negative Affect Schedule (PANAS-SF)(8 weeks)
  • Diurnal Cortisol Slope(8 weeks)
  • Salivary Sex Hormone Levels(8 weeks)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.Microbiome
NCT03457857Johnson & Johnson Consumer Inc. (J&JCI)38
Active, not recruiting
Not Applicable
Microbiome Comparison Profile of Normal Skin and Acne Vulgaris PatientsAcne Vulgaris
NCT05838534Dr.dr.Irma Bernadette, SpKK (K)144
Completed
Not Applicable
Survey of the Facial BacteriomeUnderstanding Skin Health and the MicrobiomeMicrobial Colonization
NCT04180748University Health Network, Toronto30
Recruiting
Not Applicable
Analysis of the skin microbiome in health and diseasepsoriasis and atopic dermatitis10040792
NL-OMON34787niversitair Medisch Centrum Sint Radboud80
Completed
Not Applicable
Exploration of the modulation of skin microbiota and odor components by introduction of stress in healthy male subjects.Stress-induced malodor formationMalodorSweat odor
NL-OMON44360Procter & Gamble30