The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

Sponsor
Oslo University Hospital
Study ID
NCT03656666
Phase
PHASE2
Status
Unknown

Conditions

  • Female Genital Disease
  • Lichen Planus of Vulva

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Apremilast oral tablets
  • Placebo — DRUG
    Placebo oral tablets

Study Details

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.

Key Dates

First listed
Sep 4, 2018
Start date
Sep 24, 2019
Status verified
Mar 2023
Primary completion
Nov 30, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Mean GELP score at week 24 in apremilast-treated patients versus placebo-treated patients [ Time Frame: 24 weeks ]

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