Prescription azelaic acid (15 to 20%) vs cosmetic serums (about 10%)
Every row cites its source. Where a cell reflects our own reading of the evidence rather than an external source, the row says so.
Same molecule, different legal object, different evidence. This is the comparison the skincare market least wants drawn, with the receipts for each cell.
| Aspect | Prescription 15% gel/foam and 20% cream | Cosmetic serums (commonly about 10%) | Source |
|---|---|---|---|
| Legal status | FDA-approved prescription drugs: NDA 021470, 207071, 020428, plus generic ANDAs | Cosmetics. No FDA premarket approval; azelaic acid is not an OTC drug monograph ingredient | source |
| Manufacturing oversight | Drug approval includes FDA review of manufacturing and labeling | No premarket review; FDA acts only against marketed products that break the law | source |
| Randomized-trial evidence | Pivotal programs in 664 and 1362 rosacea subjects; acne trials vs vehicle, tretinoin, BPO, clindamycin, adapalene; melasma trials vs hydroquinone | One 8-week, 23-person split-face cosmetic study of a 10% + retinal combination measuring texture and redness; no monotherapy RCT for acne, rosacea or melasma at 10% | source |
| What the evidence measures | Lesion counts, investigator global assessment, MASI: disease endpoints | Imaging-based texture, redness and pore appearance: cosmetic endpoints | source |
| Tolerability data | Quantified per label: 29% burning/stinging (gel), 6.2% site pain (foam), 1 to 5% (cream) | No label; adverse-event reporting for cosmetics is not drug-grade | source |
| Claims allowed | Approved indications: rosacea papules and pustules; inflammatory acne | Cosmetic claims only; a serum claiming to treat acne or rosacea is making a drug claim without a drug approval | source |
| Access | Prescription required in the United States | Shelf purchase | source |