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Trial record 5 of 15 for:    sol-gel

A Study of S5G4T-1 in the Treatment of Papular-Pustular 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564119
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

Brief Summary:
To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 Vehicle when applied once daily for 12 weeks in patients with papulopustular rosacea

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: S5G4T-1 Drug: S5G4T-2 Phase 3

Detailed Description:
In this Phase 3, double blind, vehicle controlled study, patients will be admitted into this multi center, double blind, randomized, vehicle controlled, parallel group pivotal study only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female patients at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: S5G4T-1
topical cream
Drug: S5G4T-1
once a day topical cream

Placebo Comparator: S5G4T-2
topical cream
Drug: S5G4T-2
once a day topical cream




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) [ Time Frame: week 12 ]
    Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the IGA relative to Baseline at Week 12.

  2. Lesion Counts [ Time Frame: week 12 ]
    Absolute change in inflammatory lesion counts from baseline to Week 12.


Secondary Outcome Measures :
  1. Percent change in lesion count [ Time Frame: week 12 ]
    Percent change in inflammatory lesion count at Week 12



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 this study.
  2. Male and female 18 years of age and older.
  3. Patients must have clinical diagnosis of moderate to severe rosacea.
  4. Have a minimum total of 15.
  5. Have two nodules or less .

Exclusion Criteria:

  1. 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.
  2. Presence of more than 2 facial nodules or any nodule greater than 1 cm.
  3. Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564119


Locations
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United States, New York
Sol-Gel 224
Rochester, New York, United States, 14623
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03564119    
Other Study ID Numbers: SGT-54-02
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sol-Gel Technologies, Ltd.:
papulopustular rosacea
Additional relevant MeSH terms:
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Rosacea
Skin Diseases