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A 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448939
Recruitment Status : Completed
First Posted : February 28, 2018
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

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.

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, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants 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 : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 18, 2018
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : May 24, 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
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
Drug: S5G4T-1
Once a day topical cream
Other Name: Encapsulated benzoyl peroxide (E-BPO) cream

Placebo Comparator: S5G4T-2 Vehicle Cream
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Drug: S5G4T-2
Once a day topical cream
Other Name: Vehicle cream




Primary Outcome Measures :
  1. Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 [ Time Frame: Baseline through Week 12 ]
    Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)".

  2. Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, 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.



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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. Participants 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. Participants must have clinical diagnosis of moderate to severe rosacea.
  4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
  5. Have 2 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 centimeter (cm).
  3. Current or past ocular rosacea (for example, 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): NCT03448939


Locations
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United States, Florida
Sol-Gel
Tampa, Florida, United States, 33607
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
  Study Documents (Full-Text)

Documents provided by Sol-Gel Technologies, Ltd.:
Study Protocol  [PDF] October 24, 2018
Statistical Analysis Plan  [PDF] April 24, 2019

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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03448939    
Other Study ID Numbers: SGT-54-01
First Posted: February 28, 2018    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: December 2021

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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
Benzoyl Peroxide
Dermatologic Agents