The AP-GELP Study: A Randomized, Placebo-Controlled Clinical Trial on the Effects of Phosphodiesterase 4-Inhibitor Apremilast in Female Genital Erosive Lichen Planus
Who is this study for? Patients with female genital erosive lichen planus
What treatments are being studied? Apremilast
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Genital erosive lichen planus (GELP) is a chronic inflammatory disease causing painful genital sores and scarring in women. Treatment options are limited and often unsatisfactory. This trial will study the effects of treatment with apremilast and quality of life and sexual function in women with GELP.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory
• Informed consent from the patient to the protocol and clinical procedures.
Locations
Other Locations
Norway
Oslo University Hospital HF
Oslo
Time Frame
Start Date: 2019-09-24
Completion Date: 2023-12-31
Participants
Target number of participants: 42
Treatments
Active_comparator: Apremilast
Week 0-24: 21 patients will receive apremilast oral tablets with initial standard titration of dose day 1-6 followed by standard dose of 30 mg apremilast b.i.d.~Initial titration:~Day 1: 10 mg in morning. Day 2: 10 mg in morning and 10 mg in evening. Day 3: 10 mg in morning and 20 mg in evening. Day 4: 20 mg in morning and 20 mg in evening. Day 5: 20 mg in morning and 30 mg in evening. Day 6 and thereafter: 30 mg twice daily.
Placebo_comparator: Placebo + Apremilast
Week 0-24: 21 patients will receive matching placebo oral tablets, with initial titration.
Related Therapeutic Areas
Sponsors
Collaborators: Amgen, Celgene Corporation
Leads: Oslo University Hospital