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

NCT03656666 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-29

No results posted yet for this study

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.

Conditions

  • Lichen Planus of Vulva
  • Female Genital Disease

Interventions

DRUG

Apremilast

Apremilast oral tablets

DRUG

Placebo

Placebo oral tablets

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Anne Lise Helgesen, MD PhD · Oslo University Hospital HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2022-11-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656666 on ClinicalTrials.gov