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Also known as Soolantra® Ivermectin cream 1%
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 a small molecule topical cream being developed for the treatment of facial rosacea. It is a Phase 3 investigational product sponsored by Assertio Holdings, Inc. (ASRT). The formulation is applied as a cream and has been studied in a randomized, double-blind, placebo-controlled trial.
Soolantra Ivermectin 1% is used for the treatment of moderate to severe facial rosacea. The Phase 3 trial enrolled 525 participants aged 18 years and older in the United States. The condition studied was facial rosacea, a chronic inflammatory skin disorder affecting the face.
Soolantra Ivermectin 1% is developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is the sponsor of the clinical program for this topical ivermectin cream 1% product.
Soolantra Ivermectin 1% is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and there are currently no active trials listed. The product remains investigational and has not been approved by the FDA for the studied indication.
Soolantra Ivermectin 1% has been evaluated in one completed Phase 3 trial, NCT04106726, titled Bioequivalence Study of Ivermectin Cream 1% in Treatment of Moderate to Severe Facial Rosacea. The trial enrolled 525 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Soolantra Ivermectin 1% is also known as Soolantra Ivermectin cream 1%. Both names refer to the same topical small molecule product developed by Assertio Holdings, Inc. for facial rosacea.