Ivermectin 0.9% | Azelaic Acid 12% | Niacinamide 3%

Route: Topical. Apply a thin layer to the entire affected facial area (or as directed) once daily or twice daily as prescribed. Avoid contact with eyes, mouth, and mucous membranes. Sun protection (SPF ≥30) is recommended during treatment. Apply gently; do not rub aggressively on inflamed or sensitive rosacea-prone skin.

Dosing is prescriber-determined:

• Typically once to twice daily application to affected facial areas.
• Clinical improvement may be noted within 4–8 weeks of consistent use.
• Treatment duration for rosacea management is often long-term (maintenance); prescriber will define the regimen.

• Ivermectin 0.9%: Acts as a GABA-A receptor agonist and activator of glutamate-gated chloride channels in nerve and muscle cells of Demodex folliculorum and D. brevis mites, producing paralysis and death of the parasites. Additionally inhibits LPS-induced inflammatory cytokines (TNF-α, IL-1β) via NF-κB and MAPK pathway suppression and upregulates anti-inflammatory IL-10, providing both antiparasitic and anti-inflammatory activity relevant to rosacea.
• Azelaic Acid 12%: Competitively inhibits mitochondrial oxidoreductases in hyperactive melanocytes (anti-pigmentation), inhibits tyrosinase, provides bacteriostatic activity against C. acnes, inhibits reactive oxygen species (ROS) generation by neutrophils, and normalizes follicular keratinization to reduce comedone formation and inflammatory papules.
• Niacinamide 3%: Increases NAD+/NADH ratio in keratinocytes (supporting antioxidant capacity), stimulates ceramide and fatty acid synthesis (restoring stratum corneum barrier), inhibits melanosome transfer from melanocytes to keratinocytes, and suppresses inflammatory cytokines — complementing ivermectin's anti-inflammatory activity.

This triple-combination targets multiple pathogenic mechanisms of papulopustular rosacea: Demodex-triggered inflammation (ivermectin), bacterial and neutrophil-mediated inflammation (azelaic acid), and barrier dysfunction/pigmentary changes (niacinamide). Prescriber-directed for patient-specific management of rosacea papules/pustules, background erythema-associated inflammation, and post-rosacea dyschromia. This formulation is particularly appropriate for patients not fully controlled by single-agent topical therapy.

Monitoring: Clinical lesion counts and erythema assessment at 8–12 weeks; skin tolerance evaluation; dermatologic reassessment if no improvement at 12 weeks.

Contraindications:

• Known hypersensitivity to ivermectin, azelaic acid, niacinamide, or formulation components.

Warnings & Precautions:

• Avoid periorbital and mucosal application of azelaic acid and ivermectin.
• Pregnancy: azelaic acid — insufficient topical safety data for category; ivermectin topical — minimal systemic absorption expected but limited pregnancy data; discuss with prescriber.
• Niacinamide: generally safe; rare transient flushing at higher concentrations.

Drug Interactions:

• No significant topical drug interactions established at these concentrations.

Common Side Effects: Mild burning, stinging, pruritus, or skin dryness at application site (most common with azelaic acid). Rare: contact dermatitis.

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

How does ivermectin help rosacea?

Ivermectin works through two complementary mechanisms in rosacea: it eradicates Demodex mites (which are found in elevated numbers in rosacea-affected skin and trigger inflammatory reactions), and it directly inhibits pro-inflammatory cytokines (TNF-α, IL-1β) involved in rosacea inflammation.

What does azelaic acid do in this formula?

Azelaic acid reduces rosacea-associated inflammation by inhibiting neutrophil reactive oxygen species, is bacteriostatic, normalizes keratinization, and inhibits tyrosinase — which can reduce the post-inflammatory dyschromia that sometimes accompanies rosacea.

How long before this cream improves rosacea?

Clinical trials with ivermectin 1% cream demonstrate significant improvement in papule/pustule counts by 12 weeks. Azelaic acid also shows 8–12 week response. Consistent daily use and sun protection are key to outcomes.

Is this FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding. FDA-approved ivermectin 1% cream (Soolantra®) and azelaic acid 15% gel (Finacea®) exist as individual products; this compounded combination allows individualized multi-ingredient therapy.

Should I wear sunscreen while using this cream?

Yes. Daily broad-spectrum sunscreen (SPF ≥30) is strongly recommended, as UV exposure is a key rosacea trigger and may worsen photosensitivity associated with azelaic acid.