Approval Probability
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Soolantra Ivermectin 1% · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Test: Ivermectin cream 1% | EXPERIMENTAL | Manufactured by Zydus Worldwide DMCC; Apply cream to the affected areas of the face once daily for 12 weeks. |
| Reference: Soolantra® cream, 1% | ACTIVE_COMPARATOR | Manufactured by Galderma Laboratories, L.P.; Apply cream to the affected areas of the face once daily for 12 weeks. |
| Placebo: Placebo for Ivermectin cream 1% | PLACEBO_COMPARATOR | Manufactured by Zydus Worldwide DMCC; Apply to the affected areas of the face once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Soolantra® Ivermectin cream 1% | DRUG | Apply topically to the face once daily for 84 consecutive days. |
| Ivermectin cream 1% | DRUG | Apply topically to the face once daily for 84 consecutive days. |
| Placebo for Ivermectin cream 1% | DRUG | Apply topically to the face once daily for 84 consecutive days. |
Inclusion Criteria: 1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of facial papulopustular rosacea. 2. Subjects must have provided IRB approved written informed consent. 3. Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papu...
Soolantra Ivermectin 1% is used for the treatment of facial rosacea, specifically moderate to severe cases. It is a small molecule therapy in the dermatology therapeutic area. The drug is being developed by Assertio Holdings, Inc. and is currently in Phase 3 clinical development.
Soolantra Ivermectin 1% is a small molecule that targets the underlying inflammatory and parasitic components of rosacea. It works by reducing Demodex mite populations and exerting anti-inflammatory effects on the skin, which helps alleviate the symptoms of facial rosacea.
Soolantra Ivermectin 1% is being developed by Assertio Holdings, Inc., a company traded on the stock exchange under the ticker symbol ASRT. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of facial rosacea.
Soolantra Ivermectin 1% is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess its bioequivalence and efficacy in treating moderate to severe facial rosacea.
Soolantra Ivermectin 1% has one completed Phase 3 clinical trial, identified as NCT04106726. This trial was a randomized, double-blind, placebo-controlled study that enrolled 525 participants with moderate to severe facial rosacea in the United States. The study has been completed.
Soolantra Ivermectin 1% is a specific formulation of ivermectin, containing 1% ivermectin as the active ingredient. It is designed for topical use in treating facial rosacea, whereas ivermectin is also available in other forms for different indications. The drug is being developed specifically for this dermatological condition.