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MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3

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: NCT04059523
Recruitment Status : Completed
First Posted : August 16, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

Brief Summary:
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: S6G5T-3 Drug: Retin-A® 0.1% Cream Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : February 6, 2020
Actual Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: S6G5T-3
topical cream
Drug: S6G5T-3
once daily

Active Comparator: Retin-A® 0.1% Cream
topical cream
Drug: Retin-A® 0.1% Cream
once daily




Primary Outcome Measures :
  1. Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration [ Time Frame: 14 days ]
    The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects 9 years of age or older.
  2. Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
  3. Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
  4. All females of child-bearing potential and premenarchal, excluding women who are surgically sterile

Exclusion Criteria:

  1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
  2. Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
  3. Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
  4. Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.

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): NCT04059523


Locations
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United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies, Inc
College Station, Texas, United States, 77845
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT04059523    
Other Study ID Numbers: SGT-65-03
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents