Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 2% CHG Cloth solution
2% CHG Cloth · 1 trial · 1 indication
Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
| Arm | Type | Description |
|---|---|---|
| 2% CHG Cloth | EXPERIMENTAL | Chlorhexidine Gluconate 2% |
| Vehicle Cloth | PLACEBO_COMPARATOR | Excipients on cloth |
| DynaHex (2% CHG) | ACTIVE_COMPARATOR | Chlorhexidine Gluconate 2% solution |
| Saline | SHAM_COMPARATOR | 0.9% sodium chloride |
| Sodium Lauryl Sulfate (SLS) | ACTIVE_COMPARATOR | Sodium lauryl sulfate to produce mild irritation as a positive control |
| Name | Type | Description |
|---|---|---|
| 2% CHG Cloth solution | DRUG | Investigational CHG |
| Vehicle Cloth | DEVICE | Excipients from CHG cloth only |
| Active Comparator | DRUG | Active comparator |
| Saline | OTHER | Negative control |
| SLS | OTHER | Provides a slight irritation for a positive control |
Inclusion Criteria: * Free of skin disorders * Signed consent Exclusion Criteria: * Allergies to latex * Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing * severe illness * Pregnant (females)
2% CHG Cloth is a small molecule product developed by Medline Inc. (ticker MDLN) for use in surgery. It is a chlorhexidine gluconate cloth, and it has been studied in a Phase 3 clinical trial. It is also known as 2% CHG Cloth solution.
2% CHG Cloth is used in surgery. Its only listed indication is surgery, and the single Phase 3 trial supporting it enrolled patients in a surgical setting. The trial evaluated irritation and sensitization of the chlorhexidine gluconate cloth in 249 participants.
2% CHG Cloth is developed by Medline Inc., which trades under the ticker MDLN. Medline is the sponsor of the Phase 3 trial of the product, NCT02224625, titled Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth.
2% CHG Cloth is in Phase 3 development. Its single registered trial, NCT02224625, is a completed Phase 3 study. The product is investigational, and the available information does not indicate that it has received FDA approval.
2% CHG Cloth has been studied in one clinical trial, NCT02224625, titled Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth. That Phase 3 trial is completed, enrolled 249 participants in the United States, was randomized and placebo controlled, and included healthy volunteers aged 16 years and older.
Yes. 2% CHG Cloth is also known as 2% CHG Cloth solution. Both names refer to the same Medline Inc. product, a chlorhexidine gluconate cloth in Phase 3 development for surgery, studied in trial NCT02224625.