NCT03448939

Brief Summary

To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_3

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

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2019

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 14, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

February 22, 2018

Results QC Date

November 9, 2021

Last Update Submit

December 13, 2021

Conditions

Papulopustular Rosacea

Keywords

papulopustular rosacea

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12

    Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)".

    Baseline through Week 12

  • Change From Baseline in Inflammatory Lesion Counts at Week 12

    Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    Baseline, Week 12

Secondary Outcomes (1)

  • Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

    Baseline, Week 12

Study Arms (2)

S5G4T-1

EXPERIMENTAL

Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.

Drug: S5G4T-1

S5G4T-2 Vehicle Cream

PLACEBO COMPARATOR

Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.

Drug: S5G4T-2

Interventions

S5G4T-1DRUG

Once a day topical cream

Also known as: Encapsulated benzoyl peroxide (E-BPO) cream
S5G4T-1
S5G4T-2DRUG

Once a day topical cream

Also known as: Vehicle cream
S5G4T-2 Vehicle Cream

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)

Sol-Gel

Tampa, Florida, 33607, United States

Location

Related Publications (1)

  • Bhatia ND, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, Nov O, Ram V, Stein Gold L. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):34-40.

    PMID: 37636253DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Sol-Gel
Organization
Sol-Gel Technologies, Ltd.
info@sol-gel.com
972-8-9313433

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

June 18, 2018

Primary Completion

May 24, 2019

Study Completion

May 24, 2019

Last Updated

December 14, 2021

Results First Posted

December 14, 2021

Record last verified: 2021-12

Locations

US(1)