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Completed

NCT Number: NCT04059523

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DermResearch, Inc., Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

S6G5T-3

Drug

once daily

Retin-A® 0.1% Cream

Drug

once daily

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sol-Gel Technologies, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2019
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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