Soolantra (ivermectin) Cream, 1% represents a significant advancement in the dermatological management of papulopustular rosacea. This prescription-only topical formulation is specifically engineered to target the inflammatory component of this chronic cutaneous condition. Its efficacy is rooted in a dual mechanism of action, combining anti-parasitic and anti-inflammatory properties to address the underlying pathophysiology. For healthcare providers seeking a well-tolerated, once-daily monotherapy that demonstrably reduces lesion count and improves overall skin quality, Soolantra offers a clinically proven, mechanism-driven solution.

Features

• Contains 1% ivermectin as the active pharmaceutical ingredient.
• Formulated in a light, non-comedogenic, oil-in-water vanishing cream base.
• Designed for once-daily topical application to the entire face.
• Delivered in a 30-gram pump dispenser, providing a consistent and measurable dose.
• Prescription-only medication, ensuring supervised use under a physician’s care.

Benefits

• Mechanism-Targeted Efficacy: Directly addresses the suspected role of Demodex folliculorum mites and associated inflammation in the pathogenesis of rosacea, leading to a significant reduction in inflammatory lesions (papules and pustules).
• Sustained Clinical Improvement: Demonstrated in clinical trials to provide continuous improvement in investigator and patient assessments over the course of 12 weeks of treatment, with many patients achieving and maintaining clear or almost clear skin.
• Superior Patient Tolerability: The hypoallergenic, non-comedogenic base is specifically formulated for sensitive, rosacea-prone skin, minimizing the risk of irritation, dryness, and peeling commonly associated with other topical therapies.
• Simplified Treatment Regimen: A once-daily application regimen enhances patient adherence and integrates seamlessly into existing skincare routines, improving long-term treatment outcomes.
• Monotherapy Potential: Provides effective control of inflammatory lesions as a single agent, potentially reducing the need for complex multi-product regimens and minimizing cumulative skin irritation.

Common use

Soolantra (ivermectin) Cream, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. It is specifically intended for adult patients presenting with the papulopustular subtype of the condition. Its use is centered on reducing the count of visible inflammatory lesions (papules and pustules) and ameliorating the associated erythema. It is not indicated for other forms of rosacea, such as phymatous or ocular rosacea, nor is it a treatment for acne vulgaris. Diagnosis and confirmation of the appropriate indication should always be made by a qualified healthcare professional.

Dosage and direction

For topical use only. Not for oral, ophthalmic, or intravaginal use.

• Application Frequency: Apply a thin layer of Soolantra Cream to the entire face once daily.
• Application Area: Apply to the entire face (forehead, chin, nose, and each cheek), avoiding the eyes, lips, and mucous membranes.
• Amount: Use approximately one pump (a pea-sized amount) for each area of the face (forehead, chin, nose, each cheek), dispensing and spreading gently.
• Method: Wash hands before and after application. Apply to clean, dry skin. The cream should be rubbed in completely and allowed to dry before applying any other skincare products or cosmetics.
• Duration: Use as directed by a physician. Clinical studies demonstrated efficacy over a 12-week treatment period. The need for continued therapy should be reassessed by the prescribing physician.

Precautions

• For External Use Only: Soolantra is for use on the skin only. If contact with the eyes occurs, rinse thoroughly with water.
• Irritation: If severe skin irritation or hypersensitivity occurs, discontinue use and consult a physician.
• Underlying Conditions: Use with caution in patients with known severe skin conditions that may compromise the skin barrier, as systemic absorption, while low, may be increased.
• Sun Exposure: While the vehicle is not known to be phototoxic, patients with rosacea are generally advised to minimize sun exposure and use broad-spectrum sunscreen daily, as UV radiation is a common trigger for flare-ups.
• Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topically applied ivermectin is excreted in human milk. Caution should be exercised when Soolantra is administered to a nursing woman.

Contraindications

Soolantra Cream is contraindicated in patients with a known hypersensitivity to ivermectin or to any of the excipients in the formulation. A detailed patient history should be taken to rule out previous allergic reactions to these components.

Possible side effect

The most common adverse reactions reported in clinical trials were skin-related and generally mild to moderate in severity. These include:

• Skin burning sensation
• Skin irritation
• Pruritus (itching)
• Dry skin The incidence of these events in patients treated with Soolantra was similar to that of the vehicle (placebo) cream. In rare cases, severe skin reactions may occur.

Drug interaction

Formal drug interaction studies have not been conducted with topical ivermectin. Given the minimal systemic absorption of ivermectin following topical application (~0.1% of the applied dose in animal studies), systemic drug interactions are considered unlikely. However, the potential for interactions with other concurrently applied topical medications (e.g., other topical anti-acne or rosacea preparations containing retinoids, benzoyl peroxide, azelaic acid, or sulfacetamide) exists and may increase the potential for cumulative local skin irritation. It is advisable to consult a physician before combining topical therapies.

Missed dose

If a dose is missed, the patient should apply it as soon as remembered. However, if it is almost time for the next scheduled application, the missed dose should be skipped, and the regular dosing schedule resumed. The patient should not apply a double dose to make up for a missed application.

Overdose

Topical overdose of Soolantra is unlikely to lead to life-threatening effects due to low systemic absorption. Excessive topical application may, however, increase the potential for severe skin irritation (e.g., erythema, scaling, burning). In the event of accidental ingestion, supportive and symptomatic treatment is recommended. Due to the low bioavailability of oral ivermectin from the cream formulation, systemic effects similar to oral ivermectin overdose (e.g., dizziness, nausea, vomiting, diarrhea) are possible but highly improbable. Medical attention should be sought in case of accidental ingestion.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Keep the tube tightly closed and in the original carton to protect from light.
• Keep out of reach of children and pets.
• Do not freeze.
• Discard any unused product 3 months after first opening the pump.

Disclaimer

This information is provided for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content is based on the product’s prescribing information but may not be exhaustive.

Reviews

• Clinical Trial Data (NEJM, 2014): A pivotal 12-week, randomized, double-blind, vehicle-controlled study involving 962 patients demonstrated that ivermectin 1% cream was significantly superior to vehicle in achieving investigator’s global assessment (IGA) success (clear or almost clear skin) and reducing inflammatory lesion counts. Ivermectin cream also showed superior improvement in quality of life scores.
• Long-Term Study (JDD, 2015): A 40-week extension study confirmed the long-term efficacy and safety of ivermectin 1% cream, with 73.7% of patients maintaining clear or almost clear skin with continuous once-daily use and a favorable safety profile consistent with the initial studies.
• Expert Consensus (Dermatology Therapy, 2017): International rosacea experts have recognized ivermectin 1% cream as a first-line monotherapy for papulopustular rosacea, citing its targeted mechanism, high efficacy, and excellent tolerability profile compared to traditional therapies like metronidazole.