Crisaborole,
does it really help with ISGA treatment success in mild-to-moderate atopic dermatitis?
research showsCrisaborole is rated C. Two 28-day phase 3 trials increased ISGA success by 7.4 and 13.4 percentage points over vehicle, but vehicle response was also high at 18.0% to 25.4%, and all decisive evidence consists of short Anacor and Pfizer development-program trials.
ads claimMarketing can expand the nonsteroidal property into a strong, durable skin-clearing effect. Direct evidence shows a limited absolute difference in 28-day ISGA success.
Useful facts when choosing a product
- ISGA success required both clear or almost clear status, a score of 0 or 1, and at least a two-grade improvement from baseline.
- AD-301 randomized 763 and AD-302 randomized 764 in a 2:1 ratio to crisaborole 2% ointment or matching vehicle twice daily for 28 days.
What the research actually shows
AD-301 randomized 763 and AD-302 randomized 764. Their primary-outcome analysis denominators were 503 crisaborole and 256 vehicle, and 513 and 250, respectively, distinct from the randomized totals. Day-29 ISGA success was 32.8% versus vehicle 25.4%, a 7.4-point difference, P=0.038, in AD-301 and 31.4% versus vehicle 18.0%, a 13.4-point difference, P<0.001, in AD-302. Both trials were parallel confirmatory studies in the same Anacor development program, so they give R1 rather than independent multiple replication. High vehicle attainment and limited absolute benefit support E~. The pooled mild-disease subgroup difference was 3.6 points (95% CI -3.9 to 11.2), P=0.35. Verdicts 742 and 823 concern systemic therapy for moderate-to-severe disease, whereas this verdict concerns topical therapy for mild-to-moderate disease.
Why this is classified as C (52)
P, R1, I0, E~, and B1 derive C with 52 points because both trials belong to the same Anacor parallel confirmatory program rather than independent replication.
Counterpoint. These vehicle-controlled trials do not establish superiority over topical corticosteroids or calcineurin inhibitors. Lesion location, age, relapse pattern, and previous treatment response matter.
Rejudgment record. Cross-check applied — Accepted ISGA success in two 28-day phase 3 trials while applying ceilings for limited absolute benefit, high vehicle response, and manufacturer-only short-term evidence
| Endpoint | P | Patient-reported treatment goal - the symptom is the goal |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E~ | Statistically positive but below the threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Day-29 ISGA treatment success | C | Both phase 3 trials succeeded, with absolute differences of 7.4 and 13.4 percentage points. |
| Achievement of clear or almost clear skin | C | Vehicle response was also high, limiting the added benefit attributable to crisaborole. |
| Early improvement in pruritus | C | Positive secondary signals do not exceed the ceiling imposed by a short manufacturer program. |
Cross-check — Codex and Claude
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Paller AS et al.; AD-301. 2016 | Phase 3 multicenter randomized double-blind vehicle-controlled trial | 256 | Manufacturer sponsorship by Anacor Pharmaceuticals with employee coauthors | Day-29 ISGA 0 or 1 with at least a two-grade improvement | 32.8% versus 25.4%, absolute difference 7.4 points, P=0.038; primary endpoint succeeded | First positive confirmatory trial |
| Paller AS et al.; AD-302. 2016 | Phase 3 multicenter randomized double-blind vehicle-controlled trial | 250 | Manufacturer sponsorship by Anacor Pharmaceuticals with employee coauthors | Day-29 ISGA 0 or 1 with at least a two-grade improvement | 31.4% versus 18.0%, absolute difference 13.4 points, P<0.001; primary endpoint succeeded | Replicated positive confirmatory trial |
| Ahmed A et al. 2018 critical appraisal | Independent critical appraisal of the two phase 3 trials | 1,527 | Academic critical appraisal with no manufacturer sponsorship reported | Absolute ISGA-success effect and the mild-disease subgroup | Pooled mild-subgroup difference 3.6 points (95% CI -3.9 to 11.2), P=0.35; highlighted limited overall magnitude | Effect-magnitude interpretation |
Receipt — 2 References
All 2 cited sources were verified for existence at the original page (as of 2026-07-24).
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-07-24 · Corrections: none
Cite this verdict
[Chamgap] Crisaborole x treatment success in mild-to-moderate atopic dermatitis — Evidence Grade C·52. 2 cited sources checked. Source: https://chamgap.com/en/verdicts/skin-hair/crisaborole-mild-moderate-atopic-dermatitis-isga-success/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
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Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.