Roflumilast Cream for Eczema: Reading the INTEGUMENT Trials
Roflumilast cream is a prescription option that acts on a pathway called phosphodiesterase-4. Its clinical trials answer a specific question: how did one strength perform against its inactive cream base over four weeks?
The study in numbers
In the 2024 INTEGUMENT-1 and INTEGUMENT-2 trials, 1,337 people aged 6 years and older with mild-to-moderate atopic dermatitis were randomized to roflumilast 0.15% or vehicle cream. At week four, 32.0% versus 15.2% reached the clinician-rated success measure in the first trial; in the second, 28.9% versus 12.0% did so. Success meant clear or almost clear skin and at least a two-grade improvement.
| What it tells us | What it does not tell us |
|---|---|
| More participants reached the specified goal with the prescription in these trials. | It does not predict one person's response or compare this medicine with a store moisturizer. |
| The main comparison lasted four weeks. | Four weeks alone cannot establish every long-term outcome. |
Why the strength matters
The U.S. label distinguishes strengths and ages. Its 0.15% cream is indicated for mild-to-moderate atopic dermatitis in patients age 6 and older; the label also has a pediatric formulation for younger children. A pharmacist can check the exact tube, age, directions and interactions. Do not exchange strengths or use it in the eyes.
For another prescription in the same broad enzyme-inhibitor family, read the crisaborole evidence guide. Our medicine-versus-moisturizer label guide explains why a cosmetic and a prescription have different jobs.
For everyday dry-skin hydration, Dr. Arsy Moisturizer #003 is a cosmetic moisturizer for dry, sensitive and eczema-prone skin. It does not treat eczema or replace prescribed care. The studies discussed did not test #003.
NIAMS: Learn more about atopic dermatitis.
Educational information from the Dr. Arsy editorial team; discuss personal medical decisions with your clinician. Cited researchers and organizations do not endorse this product. Image is an AI-generated editorial illustration.