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Ivermectin 1.2% | Niacinamide 4%

Ivermectin 1.2% | Niacinamide 4% is a dermatology-focused preparation for prescriber-directed skin protocols. Ingredient selection should reflect the patient's diagnosis, skin type, tolerability, pregnancy status, and treatment goal.

CreamTopicalRx Only503A Compounded

Ivermectin 1.2% | Niacinamide 4% is a compounded topical two-ingredient preparation combining a slightly higher ivermectin concentration with a mid-strength niacinamide for prescriber-directed management of rosacea and Demodex-associated skin conditions. This streamlined combination provides both antiparasitic/anti-inflammatory activity (ivermectin) and skin barrier-restorative, anti-inflammatory, and melanin-transfer-inhibiting activity (niacinamide). Genesis Compounding prepares this as a prescription-only, patient-specific, 503A compounded preparation not FDA-approved as a compounded product.

Active IngredientPharmacologic Role
Ivermectin 1.2%Avermectin at a slightly enhanced concentration above standard 1% for increased antiparasitic/anti-inflammatory activity; eradicates Demodex mites and suppresses cytokine-driven rosacea inflammation.
Niacinamide 4%Mid-concentration vitamin B3 that enhances skin barrier ceramide synthesis, inhibits melanosome transfer, exerts anti-inflammatory effects, and reduces sebaceous activity — complementing ivermectin's anti-inflammatory mechanism in rosacea.

Route: Topical. Apply a thin layer to affected facial skin once to twice daily as directed. Avoid eyes and mucous membranes. The simplified two-ingredient formulation is well-tolerated across most skin types.

Dosing is prescriber-determined:

  • Typically once or twice daily to affected areas.
  • Clinical response expected at 8–12 weeks; maintenance dosing often ongoing for rosacea control.
  • Prescriber specifies application timing, frequency, and treatment duration.
  • Ivermectin 1.2%: Activates glutamate-gated chloride channels (GluCl) and GABA-A receptor subtypes in Demodex mite nerve and muscle, causing hyperpolarization and paralytic death of mites. In human skin keratinocytes, suppresses NF-κB and MAPK signaling pathways, downregulating TNF-α, IL-1β production and upregulating anti-inflammatory IL-10.
  • Niacinamide 4%: Inhibits Rab3a-mediated melanosome transfer pathway (reducing post-inflammatory pigmentation); increases NAD+/NADH levels supporting cellular redox balance; stimulates ceramide and free fatty acid synthesis in keratinocytes (restoring TEWL barrier function); suppresses inflammatory cytokines (IL-6, TNF-α) via NAD+-dependent mechanisms; reduces sebaceous gland activity.

This two-ingredient formulation is suited for prescriber-directed management of papulopustular rosacea where a simplified regimen is preferred or where concurrent pigmentation treatment is handled by a separate formulation. The 1.2% ivermectin concentration (above the FDA-approved 1%) is prescribed patient-specifically for patients where the prescriber has determined a higher antiparasitic/anti-inflammatory dose may be beneficial.

Monitoring: Clinical response at 8–12 weeks; skin tolerance; Demodex mite count if clinically assessed; skin barrier function.

Contraindications:

  • Known hypersensitivity to ivermectin or niacinamide or formulation components.

Warnings & Precautions:

  • Ivermectin 1.2% (above FDA-approved topical 1%): patient-specific prescribing; systemic absorption from topical formulations is low.
  • Avoid periorbital application.
  • Niacinamide: rare transient flushing at higher concentrations in sensitive individuals.

Drug Interactions:

  • Topical concentrations: no clinically significant drug interactions expected.

Common Side Effects: Mild skin irritation, erythema, burning, or pruritus. Both ingredients are generally well-tolerated.

Store at room temperature (15°C–25°C). Keep tightly sealed and away from direct light and heat. Do not freeze. Use within the beyond-use date assigned by Genesis Compounding.

Why is 1.2% ivermectin used instead of the standard 1%?

The slightly higher concentration (1.2%) is prescribed patient-specifically for individuals where the prescriber has determined enhanced antiparasitic coverage may be beneficial. Compounding allows dose individualization beyond commercially available concentrations.

What does niacinamide do for rosacea?

Niacinamide at 4% improves the skin barrier (by stimulating ceramide synthesis), reduces inflammatory cytokines, and inhibits melanin transfer — all relevant to rosacea management. The barrier repair function is particularly important as rosacea skin often has compromised stratum corneum integrity.

Is this safe for long-term use?

Both ivermectin topical and niacinamide have favorable long-term safety profiles in rosacea treatment. Your prescriber will define treatment duration and monitor periodically for tolerability and clinical response.

Is this FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding. FDA-approved ivermectin 1% cream (Soolantra®) exists; this formulation is at a higher concentration per prescriber direction.

When should I apply this cream?

As directed by your prescriber — typically once or twice daily to the affected facial areas. Avoid sun exposure without sunscreen during treatment, as UV light is a primary rosacea trigger.

Clinical References

Authoritative sources reviewed in preparing this clinical summary. Provided for prescriber reference; not a substitute for the prescriber’s clinical judgment.

Inflammatory lesions of papulopustular rosacea: ivermectin 1% cream — NICE evidence summary
NICE, 2016
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Novel Rosacea Compound, Ivermectin Cream, Offers Unique Mechanism of Action
American Health & Drug Benefits, 2019
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Mechanistic Insights into the Multiple Functions of Niacinamide
Antioxidants / PMC, 2024
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DailyMed: Ivermectin 1% Cream (Soolantra) label
NIH DailyMed / Galderma
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