Trial reportAmerican journal of clinical dermatology2016
Tolerability of Crisaborole Ointment for Application on Sensitive Skin Areas: A Randomized, Double-Blind, Vehicle-Controlled Study in Healthy Volunteers.
Trial report in American journal of clinical dermatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 53 citations in OpenAlex.
- Clinical efficacy evaluation of crisaborole ointment in the treatment of vulvar leukoplakia.Revista da Associacao Medica Brasileira (1992) · 2023Trial
- Tapinarof Versus Crisaborole for Pediatric Atopic Dermatitis: A Systematic Review and Meta-Analysis.Dermatology practical & conceptual · 2026Review
- Exploring the Therapeutic Potential of Crisaborole Gel in Atopic Dermatitis: A Review.Recent advances in drug delivery and formulation · 2026Review
- Atopic Dermatitis Management: from Conventional Therapies to Biomarker-Driven Treatment Approaches.Biomolecules & therapeutics · 2025Review
- Review
- Phosphodiesterase-4 Inhibition in the Management of Psoriasis.Pharmaceutics · 2023Review
- Safety Profile and Tolerability of Topical Phosphodiesterase 4 Inhibitors for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis.Current therapeutic research, clinical and experimental · 2022Article
- Genital and Inverse/Intertriginous Psoriasis: An Updated Review of Therapies and Recommendations for Practical Management.Dermatology and therapy · 2021Review
- Experimental Drugs with the Potential to Treat Atopic Eczema.Journal of experimental pharmacology · 2021Review
- Phosphodiesterase-4 Inhibition in Psoriasis.Psoriasis (Auckland, N.Z.) · 2021Review
- Current Perspectives on the Management of Infantile Atopic Dermatitis.Journal of asthma and allergy · 2020Review
- Crisaborole: A Novel Nonsteroidal Topical Treatment for Atopic Dermatitis.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2019Review
- New and Emerging Therapies for Pediatric Atopic Dermatitis.Paediatric drugs · 2019Article
- Atopic dermatitis: a review of topical nonsteroid therapy.Drugs in context · 2018Review
- Phosphodiesterase-4 Inhibitors for the Treatment of Inflammatory Diseases.Frontiers in pharmacology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInflammatory skin diseases such as atopic dermatitis (AD) and psoriasis often present in sensitive and thin-skinned areas that are at higher risk for topical treatment-related skin irritation (e.g., burning, stinging).
objectivesOur objective was to address the need for topical treatments that can be safely applied to these areas. We assessed the local tolerability of crisaborole topical ointment when applied to sensitive and thin-skinned areas of healthy volunteers.
methodsIn this phase I, randomized, double-blind, vehicle-controlled, single-center study, 32 subjects were randomized 3:1 to twice-daily application of crisaborole topical ointment, 2 %, (n = 24) or vehicle ointment (n = 8) for 21 days to 13 anatomic skin areas, including the face/hairline, genitals, extensor, and intertriginous areas. The primary endpoint was assessment of the frequency and severity of local tolerability symptoms (burning/stinging, erythema, and pruritus) using the Local Tolerability Scale.
resultsOverall, 98.8 % of all tolerability assessments had a grade of 0 (no signs/symptoms of irritation) and 0.1 % had a grade >1 (mild); no differences were observed in the frequency of local tolerability scores between treatment groups. The total frequency of local tolerability assessments graded >0 (none) was lower across all application sites with crisaborole ointment (0.0-2.2 %) than with vehicle ointment (2.4-7.1 %). Local tolerability did not change over time, and was comparable between sensitive and nonsensitive skin areas.
conclusionsCrisaborole ointment application to sensitive skin areas was well tolerated in healthy volunteers, supporting its potential role as a topical treatment alternative for patients with AD or psoriasis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.