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Also known as 0.3% GSK1940029 gel
0.3% GSK1940029 · 2 trials · 1 indication
Complete physical examination will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities
Vital signs measurements will include systolic and diastolic blood pressure, heart rate and temperature
Single 12-lead ECG will be obtained at each timepoint
Continuous dual lead cardiac telemetry will be performed
Clinical monitoring/observation will be done for adverse events
The patch/test sites will be evaluated for irritation potential and will be graded using a grading scale based on scales developed by Hill Top Research, Inc and cited by the United States (US) Food and Drug Administration (FDA) in the Draft Guidance for Industry: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, December 1999
Visual evaluations of the patch/test sites will be performed for irritation potential approximately 24 hours after each patch application, and will be graded using a grading scale based on scales developed by Hill Top Research, Inc and cited by the US FDA in the Draft Guidance for Industry: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, December 1999
The Facial Irritation Scoring System will be based on the Draize Scoring System with an additional Sensation of Burning/Stinging category
The derived cumulative irritation scores will be interpreted using the Lanman-Maibach classification system
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as a single App 24h (22.5h) application to 400 cm\^2 (0.3%), 400 cm\^2 (1%) or 1200 cm\^2 (1%), respectively, in each of three sequential cohorts |
| Part 2 | EXPERIMENTAL | Subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h) application to 400 cm\^2 (0.3%), 400 cm\^2 (1%) or 1200 cm\^2 (1%), respectively, in each of three sequential cohorts |
| Part 3 | EXPERIMENTAL | Each acne patient will apply a thin coat of one or two concentration of GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| 0.3% GSK1940029 gel | DRUG | Will be supplied as gel for topical application |
| 1% GSK1940029 gel | DRUG | Will be supplied as gel for topical application |
| 0.3%/1% vehicle gel only | DRUG | Will be supplied as gel for topical application |
| Sterile distilled water | OTHER | 200 µL of the solution will be applied to individual patches by using a pipette or syringe |
| 0.5% SLS in sterile distilled water | OTHER | 200 µL of the solution will be applied to individual patches by using a pipette or syringe |
| 0.1% SLS in sterile distilled water | OTHER | 200 µL of the solution will be applied to individual patches by using a pipette or syringe |
| Patch only | OTHER | Only patch will be applied |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * A subject with a clinical abnormality or laboratory parameters outside the reference rang...
0.3% GSK1940029 is an investigational small molecule topical gel being developed by GSK plc for the treatment of acne vulgaris. It is a Phase 1 candidate and has not been approved for any indication. Both of its recorded clinical trials have been completed.
0.3% GSK1940029 is being studied for the treatment of acne vulgaris, a common inflammatory skin condition. The two completed Phase 1 trials enrolled healthy adult volunteers rather than patients with active acne, so the program remains at an early stage of clinical development.
0.3% GSK1940029 is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of both Phase 1 trials of the topical gel candidate in acne vulgaris.
0.3% GSK1940029 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies and both are completed, with no active trials currently listed. The drug is investigational and has not been approved for marketing in any indication.
Two completed Phase 1 trials have evaluated 0.3% GSK1940029. NCT01984801 studied the irritation potential of the gel in 54 healthy volunteers in Australia. NCT01938482 assessed safety, tolerability and pharmacokinetics of single and 14 day repeat topical application in 55 healthy volunteers, also in Australia.
Yes. 0.3% GSK1940029 gel is the same asset as 0.3% GSK1940029. The gel designation describes the topical formulation used in the Phase 1 acne vulgaris studies, and both names refer to the same GSK plc investigational compound.