Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 chlorhexidine gluconate cloth used in surgery to reduce skin irritation and sensitization. It is applied to the skin before surgical procedures to help prevent infection. The cloth is being developed by Medline Inc. and is currently in Phase 3 clinical trials.
2% CHG Cloth is developed by Medline Inc., a company traded under the ticker MDLN. The product is a small molecule chlorhexidine gluconate cloth intended for use in surgical settings. It is currently in Phase 3 clinical development.
2% CHG Cloth is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial, NCT02224625, has been completed, and the product is being studied for use in surgery.
2% CHG Cloth has one completed Phase 3 clinical trial, NCT02224625, titled 'Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth.' The trial enrolled 249 participants in the United States, was placebo-controlled, and included healthy volunteers aged 16 and older.
Yes, 2% CHG Cloth is a chlorhexidine gluconate cloth. The active ingredient is chlorhexidine gluconate at a 2% concentration. It is used in surgical settings to reduce skin irritation and sensitization. The product is being developed by Medline Inc.