SKINORINE CREAM

Indications

Approved Uses

Acne vulgaris (mild to moderate).

Off-Label Uses

Melasma and post-inflammatory hyperpigmentation (PIH).

Dosage & Administration

Dosing by Condition

Acne vulgaris: apply a thin layer to the entire affected area twice daily (morning and evening) after cleansing and drying; if irritation occurs, use once daily temporarily.

Initial Dose

Apply a thin layer to the affected area(s) twice daily. For sensitive skin, apply once daily in the evening for the first week.

Maintenance Dose

Apply twice daily; frequency may be reduced to once daily if irritation occurs

Maximum Dose

Apply a thin layer to affected areas twice daily (morning and evening); no systemic maximum dose applies.

Dose Adjustment Notes

If significant irritation occurs, reduce to once daily; if irritation persists or is severe, temporarily discontinue until it subsides, then restart (often once daily and titrate back to twice daily as tolerated).

How to Take

Cleanse (wash) and thoroughly dry the affected skin, then apply a thin film to the entire affected area and gently rub/massage in, usually twice daily (morning and evening); wash hands after application; avoid contact with eyes, mouth, and other mucous membranes (rinse well with water if contact occurs).

Side Effects

Common Side Effects

Application-site burning/stinging/tingling, pruritus (itching), erythema (redness), dryness, and peeling/scaling/irritation.

Side Effect Frequency

Common (1-5%): pruritus, burning, stinging, tingling. Less common (<1%): erythema, dryness, rash, peeling, irritation, dermatitis, contact dermatitis. Postmarketing: worsening of asthma, vitiligo, hypopigmentation.

Safety & Warnings

Contraindications

Hypersensitivity to azelaic acid or to any excipients in the cream.

Warnings & Precautions

For external use only; avoid eyes/mouth/mucous membranes and rinse well if contact occurs; discontinue if severe irritation or hypersensitivity occurs; rare asthma exacerbation has been reported; monitor for pigment changes in susceptible patients.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant systemic drug interactions expected; use caution when combined with other topical irritants (e.g., alcohol-based products, astringents, abrasive cleansers, peeling agents) due to additive irritation.

Interaction Severity

No clinically significant drug interactions are expected with topical azelaic acid; none are commonly documented.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Elderly

Standard adult dosing

Kidney Impairment

No dose adjustment needed in renal impairment.

Liver Impairment

No dose adjustment needed in hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

May be stopped at any time; no tapering is required, but discontinue if severe irritation/hypersensitivity occurs and reassess if no improvement after an adequate trial.

Patient Counseling

Apply a thin layer to clean, dry skin over the entire affected area (not spot-only) usually twice daily; wash hands after; avoid eyes/mouth/mucosa and rinse with water if contact occurs; expect mild burning/stinging/dryness early that often improves-reduce to once daily or pause briefly if significant irritation; improvement typically begins around 4 weeks and may take 8-12 weeks for best effect; use moisturizer and daily sunscreen; monitor/report any skin lightening (especially darker skin); store below 30°C.

Monitoring Requirements

No routine laboratory monitoring; monitor clinically for local skin irritation and for hypopigmentation/skin lightening, particularly in patients with darker skin tones.

Pharmacology

Mechanism of Action

Azelaic acid has antimicrobial activity against Cutibacterium (Propionibacterium) acnes, normalizes follicular keratinization (comedolytic/anti-keratinizing effect), and has anti-inflammatory/antioxidant effects (reduces reactive oxygen species).

Onset of Action

Initial improvement is often seen in about 4 weeks, with more maximal benefit typically by 8-12 weeks of consistent use.

Half-Life

Unknown / not well established for topical azelaic acid (no clinically meaningful half-life is provided in standard labeling for the topical product).

Metabolism

Partially metabolized via beta-oxidation to shorter-chain dicarboxylic acids; overall systemic metabolism is limited due to low absorption.

Protein Binding

Unknown / not routinely reported for topical azelaic acid in standard product labeling.

Product Information

Available Dosage Forms

Cream (20%) for this SFDA-registered product; azelaic acid also exists in other products as 15% gel and 15% foam in some markets.

Composition per Dose

Each 1g of cream contains 200mg (20%) of azelaic acid.

Generic Availability

Yes

Skin Condition

Acne

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