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Introduction: Criborole ointment is a non-steroidal, topical anti-inflammatory ointment, mainly used to treat mild to moderate atopic dermatitis. Its main active ingredient, criborole, is a phosphodiesterase 4 (PDE-4) inhibitor. By inhibiting PDE-4, it increases intracellular cyclic adenosine monophosphate levels, thereby reducing the production of inflammatory mediators and exerting anti-inflammatory effects.

Criborole Ointment

is an FDA-approved topical phosphodiesterase 4 inhibitor (PDE4) drug for the treatment of mild to moderate atopic dermatitis in adults and children 3 months and older. The FDA approved criborole ointment for use in children 2 years and older in December 2016, and in March 2020 for children 3 months and older.

Mechanism of action

Criborole ointment is not a topical steroid. It works by blocking phosphodiesterase 4 (PDE4), an enzyme that helps regulate skin inflammation. When you have atopic dermatitis, the PDE4 enzyme in immune system cells may become overactive, causing inflammation. Reducing PDE4 activity can reduce or alleviate the signs and symptoms of atopic dermatitis by reducing inflammation.

Dosage

Criborole ointment is applied as a thin film directly to the affected skin area twice daily.

Clinical Efficacy

In clinical trials of criborole ointment after 28 days of continuous use, 31.4-32.8% of patients achieved an Investigator's Static Global Assessment (ISGA) of 0-1 (clear or almost clear) with at least a grade 2 improvement from initiation of use, compared to 18.0-25.4% of respondents using vehicle alone.

The Investigator's Static Global Assessment is a 5-point scale on which the investigator provides an overall clinical assessment of atopic dermatitis based on signs and symptoms. Criborole ointment has also been shown to reduce symptoms of atopic dermatitis, such as itching, redness, lichenification, purulent rashes, and rough, scratchy lesions. Some patients report these improvements after using Criborole ointment for about a week. Criborole ointment has also been shown to produce clinically meaningful improvements in patients' quality of life.

Side Effects

In clinical trials, the most common side effect of cristorole ointment was pain at the application site, such as burning or stinging, which usually improved with continued use.