Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-50
SponsorJinnah Postgraduate Medical Centre

About this trial

This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life.

Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.

Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.

Eligibility criteria

Qualifiers

Age 12 to 50 years

Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)

Willing and able to apply topical medication twice daily for four weeks

Able to provide written informed consent (parental consent for participants under 18 years)

Disqualifiers

Severe atopic dermatitis (ISGA score 4)

Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks

Known hypersensitivity to crisaborole or any component of the formulation

Pregnant or lactating women

Trial design

Treatments tested in this trial

  • Placebo Cream
  • Crisaborole 2% Cream

Treatment groups

270 Participants
are divided into 2 treatment groups

Locations

This trial has no locations