Soolantra (ivermectin) cream, 1%

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2014

Specific Treatments:

inflammatory lesions of rosacea

Therapeutic Areas

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General Information

Soolantra (ivermectin) cream is a broad-spectrum antiparasitic agent. The exact mechanism of action by which it works against rosacea is not clear.

Soolantra is specifically indicated for the treatment of inflammatory lesions of rosacea.

Soolantra is supplied as a cream for topical administration. Soolantra should be applied to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips.

Clinical Results

FDA Approval

The FDA approval of Soolantra was based on two identical randomized, double-blind, vehicle-controlled clinical trials. The trials were conducted in 1,371 subjects aged 18 years and older who were treated once daily for 12 weeks with either Soolantra cream or vehicle cream. Using the 5-point Investigator Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79% of subjects were scored as moderate (IGA=3) and 21% scored as severe (IGA= 4) at baseline. The co-primary efficacy endpoints in both pivotal trials were the success rate based on the IGA outcome (percentage of subjects “clear” and “almost clear”) and absolute change from baseline in inflammatory lesion counts at Week 12. Study 1 - IGA Outcome: 38.4% for Soolantra cream arm versus 11.6% for the vehicle arm; Inflammatory lesion count: 64.9% for the Soolantra cream arm versus 41.6% for the vehicle arm. Study 2 - IGA Outcome: 40.1% for Soolantra cream arm versus 18.8% for the vehicle arm; Inflammatory lesion count: 65.7% for the Soolantra cream arm versus 43.4% for the vehicle arm. 

Side Effects

Adverse effects associated with the use of Soolantra may include, but are not limited to, the following:

  • skin burning sensation
  • skin irritation

Mechanism of Action

Soolantra (ivermectin) cream is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. The exact mechanism of action by which it works against rosacea is not clear. 

Additional Information

For additional information regarding Soolantra or inflammatory lesions of rosacea, please visit http://www.galdermausa.com/