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

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ClinicalTrials.gov Identifier: NCT03564145
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : July 4, 2018
Sponsor:
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

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

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.
ClinicalTrials.gov 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:
Rosacea
Skin Diseases