Lichen Planus of VulvaPhase 2NCT03656666
The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus
A Phase 2 study testing Apremilast in people with Lichen Planus of Vulva and Female Genital Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Planus of Vulva, Female Genital Disease
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNorway
- Study dates
- 24 Sep 2019to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients receiving other systemic immune modulating therapy
- Concomitant use of strong CYP3A4 enzyme inducers
- Inadequate birth control, pregnancy and/or breast-feeding
- Depression and suicidal ideation
- Patients with severe renal impairment
- Patients with active tuberculosis, serious infections or cancer
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- Unexplained and clinically significant weight loss in underweight patients
- Hypersensitivity to the active substance(s) or to any of the excipients
- Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The AP-GELP Study: A Randomized, Placebo-Controlled Clinical Trial on the Effects of Phosphodiesterase 4-Inhibitor Apremilast in Female Genital Erosive Lichen Planus
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.
Read the detailed description
Genital erosive lichen planus (GELP) is a chronic, inflammatory and scarring genital disease. The disease may have a significant impact on daily living, quality of life and sexual function. There is a considerable lack of high-quality evidence on treatment options for GELP and few effective therapeutic facilities available in current clinical practice.
The aims of this study are to investigate clinical and immunohistochemical effects of a new oral anti-inflammatory treatment, apremilast, for women with moderate-to-severe GELP in a double-blinded, randomized, placebo-controlled trial (RCT). Apremilast is an inhibitor of phosphodiesterase 4 (PDE4) with documented effect in several inflammatory skin diseases, but it has not yet been studied in patients with GELP. The drug dose and study design have been chosen based on relevant experience from other studies on apremilast, and is equivalent to the dose used for approved indications (chronic plaque psoriasis and psoriatic arthritis).
The main objective of this trial is to assess the efficacy of apremilast in the treatment of GELP in women.
Secondary objectives include
- Description of immunohistochemical changes in lichen planus lesions
- Assessment of safety of apremilast in the treatment of GELP
- Assessment of quality of life and sexual function
- Conditions
- Lichen Planus of Vulva, Female Genital Disease
- Being tested
- Apremilast, Placebo
- Keywords
- apremilast, genital erosive lichen planus
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Apremilast oral tablets
PlaceboDrug
Also called Placebo (for apremilast)
Placebo oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Active comparator | 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. Receives: Drug: Apremilast |
| Placebo + Apremilast | Placebo comparator | Week 0-24: 21 patients will receive matching placebo oral tablets, with initial titration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean GELP score at week 24 in apremilast-treated patients versus placebo-treated patients
The GELP (Genital Erosive Lichen Planus) score is a scoring system for clinical assessment of genital erosive lichen planus (GELP) in women. Area of genital involvement, erythema, striae, number of erosions and pain are registered and scored 0-3 (0 is none) for each parameter. Vulval and vaginal involvement is assessed separately, resulting in a maximum GELP score of 30.
Measured: 24 weeks
Secondary outcomes (14)
Mean GELP score improvement from week 0 to week 24 in all patients
The GELP (Genital Erosive Lichen Planus) score is a scoring system for clinical assessment of genital erosive lichen planus (GELP) in women. Area of genital involvement, erythema, striae, number of erosions and pain are registered and scored 0-3 (0 is none) for each parameter. Vulval and vaginal involvement is assessed separately, resulting in a maximum GELP score of 30.
Measured: 24 weeks
Weekly use of topical steroid, collected from patient diary
Frequency of application is recorded once a week in the patient diary as the number of days being used per week
Measured: 24 weeks
Weekly VAS pain score, collected from patient diary
VAS is recorded once a week in the patient diary using a visual linear scale of 100mm ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 24 weeks
Number of patients with GELP score improvement at week 16 and 24
The GELP (Genital Erosive Lichen Planus) score is a scoring system for clinical assessment of genital erosive lichen planus (GELP) in women. Area of genital involvement, erythema, striae, number of erosions and pain are registered and scored 0-3 (0 is none) for each parameter. Vulval and vaginal involvement is assessed separately, resulting in a maximum GELP score of 30.
Measured: 24 weeks
Separate GELP score assessments: Area of involvement (in cm²)
Range 0-3 (none=0, <3 cm²=1, 3-6 cm²=2, >6 cm²=3). Recorded as part of the GELP score at time points specified in the protocol.
Measured: 24 weeks
Separate GELP score assessments: Intensity of erythema
Range 0-3 (none=0, mild=1, moderate=2, strong=3). Recorded as part of the GELP score at time points specified in the protocol.
Measured: 24 weeks
Separate GELP score assessments: Number of erosions
Range 0-3 (none=0, 1=1, 2-3=2, >3=3). Recorded as part of the GELP score at time points specified in the protocol.
Measured: 24 weeks
Separate GELP score assessments: Striae
Range 0-3 (none=0, minimal=1, moderate=2, extensive=3). Recorded as part of the GELP score at time points specified in the protocol.
Measured: 24 weeks
Separate GELP score assessments: Pressure-induced pain (VAS)
Patient-reported pain is induced by pressuring the involved area with a cotton swab, using a visual linear scale of 100mm ranging from 0 (no pain) to 10 (worst imaginable pain). GELP score range 0-3 (no pain=0, VAS 1-3=1, VAS 4-6=2,VAS 7-10=3). Recorded as part of the GELP score at time points specified in the protocol.
Measured: 24 weeks
Physician Global Assessment (PGA)
5-point disease severity scoring system, assessed by the clinician at time points specified in the protocol (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
Measured: 24 weeks
Patient Global Assessment (PtGA)
5-point disease severity scoring system, assessed by the patient at time points specified in the protocol (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
Measured: 24 weeks
DLQI score
The Dermatology Life Quality Index (DLQI) is a 10-question validated questionnaire. Each question is scored 0-3, with a maximum score of 30. The higher the score, the more quality of life is impaired. The time points for DLQI score are specified in the protocol.
Measured: 24 weeks
GHQ-28 score
GHQ-28 is a 28-item version of the General Health Questionnaire (GHQ) subdivided into somatic symptoms, anxiety/insomnia, social dysfunction and severe depression. Each question is scored 0-1. The higher the score, the more severe the condition.The time points for GHQ-28 score are specified in the protocol.
Measured: 24 weeks
Sexual function assessments
The Female Sexual Distress Scale - Revised (FSDS-R) is a 13-item questionnaire used for sexual function assessment. Each question is scored 0-4. The total score range is 0-52, with higher scores indicating more sexually related distress.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start24 Sep 2019
- Primary completion30 Nov 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planus of VulvaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Amgen
- Responsible party
- Principal investigator, Anne Lise Helgesen, Oslo University Hospital
- Investigators
- Anne Lise Helgesen, MD PhD, Principal investigator, Oslo University Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656666
- Sponsor's protocol ID
- AP-GELP
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AP-GELP Study: A Randomized, Placebo-Controlled Clinical Trial on the Effects of Phosphodiesterase 4-Inhibitor Apremilast in Female Genital Erosive Lichen Planus
- ClinicalTrials.gov ID
- NCT03656666
- Acronym / sponsor ID
- AP-GELP
- Conditions
- Lichen Planus of Vulva, Female Genital Disease
- Keywords
- apremilast, genital erosive lichen planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Celgene Corporation, Amgen
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Genital erosive lichen planus (GELP) is a chronic, inflammatory and scarring genital disease. The disease may have a significant impact on daily living, quality of life and sexual function. There is a considerable lack of high-quality evidence on treatment options for GELP and few effective therapeutic facilities available in current clinical practice.
The aims of this study are to investigate clinical and immunohistochemical effects of a new oral anti-inflammatory treatment, apremilast, for women with moderate-to-severe GELP in a double-blinded, randomized, placebo-controlled trial (RCT). Apremilast is an inhibitor of phosphodiesterase 4 (PDE4) with documented effect in several inflammatory skin diseases, but it has not yet been studied in patients with GELP. The drug dose and study design have been chosen based on relevant experience from other studies on apremilast, and is equivalent to the dose used for approved indications (chronic plaque psoriasis and psoriatic arthritis).
The main objective of this trial is to assess the efficacy of apremilast in the treatment of GELP in women.
Secondary objectives include
- Description of immunohistochemical changes in lichen planus lesions
- Assessment of safety of apremilast in the treatment of GELP
- Assessment of quality of life and sexual function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Active comparator | Drug: ApremilastWeek 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 + Apremilast | Placebo comparator | Drug: PlaceboWeek 0-24: 21 patients will receive matching placebo oral tablets, with initial titration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients receiving other systemic immune modulating therapy
- Concomitant use of strong CYP3A4 enzyme inducers
- Inadequate birth control, pregnancy and/or breast-feeding
- Depression and suicidal ideation
- Patients with severe renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: OtezlaApremilast oral tablets | Drug | Apremilast |
| PlaceboAlso: Placebo (for apremilast)Placebo oral tablets | Drug | Placebo + Apremilast |
Primary outcome
Mean GELP score at week 24 in apremilast-treated patients versus placebo-treated patients
Time frame: 24 weeks
The GELP (Genital Erosive Lichen Planus) score is a scoring system for clinical assessment of genital erosive lichen planus (GELP) in women. Area of genital involvement, erythema, striae, number of erosions and pain are registered and scored 0-3 (0 is none) for each parameter. Vulval and vaginal involvement is assessed separately, resulting in a maximum GELP score of 30.
14 secondary outcomes
Mean GELP score improvement from week 0 to week 24 in all patients
Time frame: 24 weeks
Weekly use of topical steroid, collected from patient diary
Time frame: 24 weeks
Weekly VAS pain score, collected from patient diary
Time frame: 24 weeks
Number of patients with GELP score improvement at week 16 and 24
Time frame: 24 weeks
Separate GELP score assessments: Area of involvement (in cm²)
Time frame: 24 weeks
Separate GELP score assessments: Intensity of erythema
Time frame: 24 weeks
Separate GELP score assessments: Number of erosions
Time frame: 24 weeks
Separate GELP score assessments: Striae
Time frame: 24 weeks
Separate GELP score assessments: Pressure-induced pain (VAS)
Time frame: 24 weeks
Physician Global Assessment (PGA)
Time frame: 24 weeks
Patient Global Assessment (PtGA)
Time frame: 24 weeks
DLQI score
Time frame: 24 weeks
GHQ-28 score
Time frame: 24 weeks
Sexual function assessments
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lise Helgesen, MD PhD principal investigator
Oslo University Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Lichen Planus of Vulva and Female Genital Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean GELP score at week 24 in apremilast-treated patients versus placebo-treated patients (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.