Soolantra: Targeted Topical Treatment for Inflammatory Lesions of Rosacea
| Product dosage: 30 g | |||
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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. By directly mitigating the inflammatory cascade and reducing Demodex folliculorum mite density, Soolantra offers a clinically proven, well-tolerated, and convenient therapeutic option for patients seeking to achieve and maintain clear skin.
Features
- Active Ingredient: Ivermectin 1% w/w.
- Formulation: Oil-in-water emulsion cream.
- Pharmacologic Class: Antiparasitic agent with secondary anti-inflammatory properties.
- Presentation: 30 g and 45 g tubes.
- Prescription Status: Rx-only.
- Application: For topical use only; not for ophthalmic, oral, or intravaginal use.
Benefits
- Targets the Root Cause: Addresses the potential role of Demodex folliculorum mites and the associated inflammatory response, which are believed to be key contributors to papulopustular rosacea.
- Sustained Efficacy: Demonstrated in clinical trials to provide continuous improvement in inflammatory lesion count and erythema over 12 weeks of treatment, with many patients achieving and maintaining clear or almost clear skin.
- Dual-Action Mechanism: Combines anti-parasitic effects to reduce mite density with direct anti-inflammatory properties, calming the skin and reducing redness and bumps.
- Favorable Safety Profile: Generally well-tolerated with a low incidence of systemic side effects, as the topical application minimizes systemic absorption.
- Convenient Dosing: A simple once-daily application integrates easily into a patient’s skincare routine, promoting adherence to the treatment regimen.
- Improves Skin Quality: Long-term use can lead to a reduction in the frequency and severity of flare-ups, contributing to an overall improvement in skin texture and appearance.
Common use
Soolantra (ivermectin) Cream, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. It is specifically designed for adult patients presenting with the papulopustular subtype of the condition, characterized by erythema (redness), papules (small, solid bumps), and pustules (pus-filled bumps). It is not indicated for other forms of rosacea, such as phymatous or ocular rosacea, or for the treatment of other skin disorders like acne vulgaris or perioral dermatitis. Diagnosis and confirmation of the appropriate indication should always be made by a qualified healthcare professional.
Dosage and direction
- Dosage: Apply a pea-sized amount of Soolantra cream once daily to the entire face (forehead, chin, nose, and each cheek). Avoid the eye area (eyelids), lips, and mucous membranes.
- Direction: Gently cleanse and dry the face before application. Dispense a pea-sized amount of cream onto a fingertip. Dot the cream onto the five areas of the face (forehead, chin, nose, each cheek) and then spread a thin, uniform layer over the entire face. Wash hands immediately after application.
- Duration: Use once daily for the full duration prescribed, even if symptoms appear to improve sooner. Clinical studies demonstrate continuous improvement over 12 weeks. The duration of therapy should be determined by the prescribing physician based on treatment response.
Precautions
- For External Use Only: Soolantra is for topical use on the skin only. It must not be ingested or applied to the eyes, inside the nose or mouth, or to the vaginal area.
- Irritation: If severe skin irritation or hypersensitivity occurs, discontinue use and consult a physician.
- Pre-existing Conditions: Use with caution in patients with known extensive skin barrier disruption or severe exfoliative skin conditions, as systemic absorption may be increased, though it remains low.
- Sun Exposure: Rosacea-prone skin is often sun-sensitive. While Soolantra itself is not a photosensitizer, patients should be advised to use protective measures against sunlight, including sunscreen and protective clothing, as part of a comprehensive rosacea management plan.
- Contact Lenses: Patients should be advised to apply the cream carefully to avoid accidental contact with eyes, which may cause irritation. Contact lenses should not be inserted if the cream has contacted the eyes.
Contraindications
Soolantra is contraindicated in patients with a known hypersensitivity to ivermectin, any other avermectins, or to any of the excipients in the formulation (e.g., cetyl alcohol, oleyl alcohol, stearyl alcohol, isopropyl palmitate, and carbomer copolymer type B).
Possible side effect
The most common adverse reactions reported in clinical trials were local skin reactions. These are typically mild to moderate in severity and often diminish with continued use.
- Very Common (≥1/10): Skin burning sensation.
- Common (≥1/100 to <1/10): Skin irritation, pruritus (itching), dry skin.
- Uncommon (≥1/1,000 to <1/100): Worsening of rosacea (temporary flare), contact dermatitis.
- Rare: Allergic reactions, including rash, swelling of the face and mouth (angioedema), and difficulty breathing. Discontinue use immediately and seek medical attention if signs of a serious allergic reaction occur.
Drug interaction
Formal drug interaction studies have not been conducted with topical ivermectin. Due to minimal systemic absorption (~0.1%) following topical application of Soolantra, clinically significant drug interactions are not anticipated. However, the potential for interactions with other topical products applied concurrently to the same area of skin exists. Concomitant use of other topical medications, cosmetics, or abrasive cleansers on the same area may increase the risk of skin irritation. It is advisable to consult a physician before using any other topical products on the face during treatment.
Missed dose
If a dose is missed, it should be applied as soon as remembered on the same day. If the day has passed, the patient should skip the missed dose and resume the usual dosing schedule the next day. The dose should not be doubled 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. Accidental ingestion may lead to systemic effects associated with ivermectin overdose, which could include rash, nausea, vomiting, diarrhea, dizziness, ataxia (loss of coordination), seizures, and hypotension. In case of accidental ingestion, seek immediate medical attention or contact a Poison Control Center. Topical application of excessive amounts may increase the potential for skin irritation.
Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F).
- Keep the tube tightly closed.
- Do not freeze.
- Keep out of reach of children and pets.
Disclaimer
This information is for educational purposes only and 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
- Clinical Trial Data (Pooled Analysis): In two pivotal Phase 3 studies involving over 1,300 patients, Soolantra demonstrated superior efficacy to vehicle cream. At week 12, 38.4% of patients achieved “clear” or “almost clear” skin on the Investigator’s Global Assessment (IGA) scale, compared to 11.6% with vehicle. A mean reduction of 18.2 inflammatory lesions (75.1%) was observed versus 9.0 (39.5%) for vehicle. Patients also reported significant improvements in quality of life.
- Dermatologist Endorsement: “Soolantra has become a first-line therapy in my practice for moderate papulopustular rosacea. Its targeted mechanism and excellent tolerability profile make it a reliable option. Patients appreciate the once-daily application and the sustained results they see over a 3-month period, which helps break the cycle of flare-ups.”
- Patient Feedback (Summarized): Many users report a noticeable reduction in redness and bumps within 4-8 weeks, with continued improvement. The cream is often described as cosmetically elegant, non-greasy, and easily absorbed. Some note initial, temporary skin dryness or a slight burning sensation that subsides. A common sentiment is satisfaction with having a treatment that addresses the condition effectively with minimal hassle.