NCT05919810

Brief Summary

The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 18, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

June 16, 2023

Last Update Submit

December 15, 2024

Conditions

Acne VulgarisAcneiform EruptionsSkin DiseasesSebaceous Gland Diseases

Keywords

microbiomeprobioticsdietary supplementation

Outcome Measures

Primary Outcomes (2)

  • Gut microbiome composition of short chain fatty acid producing bacteria

    Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii

    8 weeks

  • Stool acetate levels

    Assess the short chain fatty acid stool acetate levels

    8 weeks

Secondary Outcomes (2)

  • Change in salivary progesterone levels

    4 weeks

  • Change in salivary progesterone levels

    8 weeks

Other Outcomes (2)

  • Total lesion count

    4 weeks

  • Total lesion count

    8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Daily consumption of probiotic

Other: Probiotic

Oral herbal supplement

EXPERIMENTAL

Daily consumption of oral herbal supplement powder

Dietary Supplement: Oral herbal powder supplement

Interventions

ProbioticOTHER

Oral probiotic

Probiotic
Oral herbal powder supplementDIETARY_SUPPLEMENT

oral herbal powder

Oral herbal supplement

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects 12 years of age until 45 years of age
  • The presence of mild to moderate acne based on investigator global assessment.
  • Presence of at least 10 inflammatory lesions and at least 5 non-inflammatory lesions

You may not qualify if:

  • The presence of severe acne as noted by the investigator global assessment.
  • Those who are unwilling to discontinue oral probiotic-based supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
  • Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide for 2 weeks prior to enrollment
  • Those who are unwilling to keep their facial regimen the same throughout the study
  • Individuals who have been on an oral antibiotic for acne within the previous one month.
  • Individuals who are pregnant or breastfeeding.
  • Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
  • Individuals on oral contraceptive pills or progesterone or estrogen containing therapies
  • Use of isotretinoin within the three months prior to enrollment.
  • Individuals on finasteride or dutasteride
  • Current tobacco smoker or a tobacco smoking history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95819, United States

Location

Related Publications (1)

  • Min M, Afzal N, Maloh J, Dulai AS, Ahmad N, Pinzauti D, Sivamani RK. Prospective Comparative Study of an Oral Synbiotic and a Myoinositol-Based Herbal Supplement in Modifying Hormone Levels and the Gut Microbiome in Non-cystic Acne. Dermatol Ther (Heidelb). 2025 Jun;15(6):1331-1350. doi: 10.1007/s13555-025-01411-4. Epub 2025 Apr 18.

    PMID: 40246799DERIVED

MeSH Terms

Conditions

Acne VulgarisAcneiform EruptionsSkin DiseasesSebaceous Gland Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Raja Sivamani, MD MS AP

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 26, 2023

Study Start

July 3, 2023

Primary Completion

February 12, 2024

Study Completion

July 31, 2024

Last Updated

December 18, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)