NCT05675501

Brief Summary

The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following:

  • How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
  • How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2020

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

Study Start

First participant enrolled

June 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

December 1, 2022

Last Update Submit

April 16, 2023

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (5)

  • Change in skin microbiome diversity after 8-weeks of treatment compared to baseline

    Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.

    8-weeks

  • Change in transepidermal water loss after 8-weeks of treatment compared to baseline.

    transepidermal water loss in g/m2/h

    8-weeks

  • Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.

    stratum corneum water content (wt%)

    8-weeks

  • Change in sebum excretion rate after 8-weeks of treatment compared to baseline.

    sebum production in µg/cm2

    8-weeks

  • Change in colorimeter test after 8-weeks of treatment compared to baseline.

    facial L\*a\*b\* values

    8-weeks

Secondary Outcomes (5)

  • Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline

    4-weeks

  • Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.

    4-weeks

  • Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.

    4-weeks

  • Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.

    4-weeks

  • Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.

    4-weeks

Study Arms (2)

Study Drug

EXPERIMENTAL

Daily Encapsulated Benzoyl Peroxide (E-BPO) Cream, for 8 weeks (period 1). Subjects will then switch treatments to the vehicle cream for a period of 4 weeks (period 2),

Drug: Encapsulated Benzoyl Peroxide Cream

Vehicle

PLACEBO COMPARATOR

Daily Vehicle Cream, for 8 weeks (period 1). Subjects will then switch treatments to the study drug encapsulated E-BPO for a period of 4 weeks (period 2),

Drug: Encapsulated Benzoyl Peroxide Cream

Interventions

Encapsulated Benzoyl Peroxide CreamDRUG

Subjects will use a "pea-size" amount for each area of the face

Study DrugVehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
  • Male and female 18 years of age and older.
  • Participants must have clinical diagnosis of moderate to severe rosacea.
  • Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
  • Have 2 nodules or less.

You may not qualify if:

  • Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
  • Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
  • Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research (ISSR)

Sacramento, California, 95815, United States

Location

Related Publications (1)

  • Nong Y, Sugarman J, York JP, Levy-Hacham O, Nadora D, Mizrahi R, Galati A, Gallo RL, Sivamani RK. Effect of Topical Microencapsulated Benzoyl Peroxide on the Skin Microbiome in Rosacea: A Randomized, Double-Blind, Crossover, Vehicle-Controlled Clinical Trial. J Clin Aesthet Dermatol. 2024 Aug;17(8):19-26.

    PMID: 39148964DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

January 9, 2023

Study Start

June 10, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

US(1)