Folliculitis decalvans
Conditions
Brief summary
The primary endpoint is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 months.
Detailed description
Pain evaluated by Visual Analogue Scale (VAS) at randomization, 3, 6 and 12 months. Pain change from randomization, at 3, 6 and 12 months., Pruritus evaluated by WI-NRS (Worst Itch Numeric Rating Scale) at randomization, 3, 6 and 12 months, Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months, Time to first relapse during the study period, Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue), Measure of FD-IGA score (blinded assessor) at 12 months, Tolerance of drugs
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain evaluated by Visual Analogue Scale (VAS) at randomization, 3, 6 and 12 months. Pain change from randomization, at 3, 6 and 12 months., Pruritus evaluated by WI-NRS (Worst Itch Numeric Rating Scale) at randomization, 3, 6 and 12 months, Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months, Time to first relapse during the study period, Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue), Measure of FD-IGA score (blinded assessor) at 12 months, Tolerance of drugs | — |
Countries
France
Outcome results
None listed