Table 6.
Summary of doses and treatment time for approved and unapproved indications for oral isotretinoin, according to clinical studies, case series, case reports, and consensuses
| Indications | Oral isotretinoin dose | Treatment time |
|---|---|---|
| Acnes grades III and IV or unresponsive to previous treatments1, 2, 4, 5, 36, 40, 41, 42, 43, 46, 51, 52, 53, 54, 56, 58, 59, 64, 65, 67, 71, 72, 73, 74, 79, 80, 83 | 0.5–1 mg/kg/day | Up to a dose of 120–150 mg/kg/day or until complete regression of the lesions |
| Acne – “low daily dose”10, 38, 48, 55, 61, 62, 69, 71, 80, 81, 82 | 0.1–0.5 mg/kg/day | Up to 18 months or up to 1 to 2 months after lesion resolution |
| Acne flares100, 101 | Low dose (up to 8 weeks) associated with prednisone | 8 weeks low dose oral isotretinoin |
| Prednisone: 0.5–1 mg/kg/day for 2 weeks or until resolution of the flare | ||
| Severe and extensive acne associated with macrocomedones36, 42, 100, 101 | 01–0.2 mg/kg, 8 weeks, may or may not be increased gradually with fractionated prednisone used in the first 2 to 4 weeks | Low dose: 8 weeks |
| Prednisone: 2–4 weeks | ||
| Rosacea112, 113, 114, 115, 116, 117, 118, 119 | 0.25 to 0.3 mg/kg | 4 months |
| Selected cases, “microdoses”: mean 0.07 mg/kg/day, up to 33 months | Microdose: up to 33 months | |
| Rosacea fulminans120 | 0.2–0.5 mg/kg, increased up to 0.5–1 mg/kg, associated with prednisone 40–60 mg/day | 3–4 months |
| Phymatous rosacea121 | 20 mg/day active phase, maintenance at 10 mg/day | 6 months for active phase |
| Ocular rosacea125, 126 | 10 mg/day | 4 months |
| Seborrheic dermatitis139, 140, 141, 142, 143, 144 | 0.05–0.51 mg/kg/day | Mean of 33 weeks |
| Pustular psoriasis148, 149, 150 | Children: 0.75 mg/kg/day | 4 months |
| Adults: 1.5–2.0 mg/kg/day | ||
| Photoaging159, 160, 161, 162, 163, 164 | 10–20 mg 3 × /week | 2–6 months |
| Field cancerization190 | 10 mg/day | 6 months |
| Frontal fibrosing alopecia205, 206 | 20 mg/day | Mean: 13 months |
| Facial papules of frontal fibrosing alopecia207, 208, 209 | 10 mg every other day or 20 mg/day | 2–4 months |
| Dissecting cellulitis212, 213, 214, 215, 216, 217, 218, 219, 220, 221 | 0.5–1 mg/kg/day | 3–12 months |
| Low dose – 10 mg/day | ||
| Pityriasis rubra pilaris222, 223, 224 | 0.5–2 mg/kg/day | 16–24 weeks |
| Cutaneous lupus erythematosus225 | 0.2–1 mg/kg/day | 5 months |
| Generalized granuloma annulare226 | 0.5 mg/kg/day | 2–6 months, maintenance at lower doses |
| Condyloma acuminatum and recalcitrant warts227, 228 | 0.5 mg/kg/day (cervical condyloma)227 | 12 weeks |
| 0.5–1 mg/kg/day228 | Mean: 3 months | |
| Darier's disease229, 230 | 0.2 mg/kg at the beginning, increase to 0.5–1 mg/kg, according to the hue of the lesion | Continuous use (genodermatosis) |