A Long Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03564145
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : July 4, 2018
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

Brief Summary:
To assess the safety of S5G4T-1 when applied once daily for 24 to 48 weeks in patients with papulopustular rosacea

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: S5G4T-1 Phase 3

Detailed Description:
Patients from Phase 3 study may continue into an open label, long term safety extension. Patients will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in the phase 3 study. Eligible patients for enrollment will apply the study product, S5G4T-1, daily for up to 36 weeks to complete long term usage of the drug for 24 to 48 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center, Open Label, Long Term Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: S5G4T-1
Topical cream
Drug: S5G4T-1
once a day topical cream
Other Name: Study Product

Primary Outcome Measures :
  1. Adverse events [ Time Frame: week 48 ]
    including serious adverse events (SAEs) occurring at any time during the trial

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
  2. Complete 12 weeks of Phase 3.

Exclusion Criteria:

Responsible Party: Sol-Gel Technologies, Ltd. Identifier: NCT03564145     History of Changes
Other Study ID Numbers: SGT-54-07
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Skin Diseases