Genital Lichen PlanusPhase 2/3NCT01282515
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
A Phase 2/3 study testing clobetasol propionate 0,05% ointment and hexaminolevulinate in people with Genital Lichen Planus, run by Oslo University Hospital at 1 site in Norway.
Trial summary
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Lichen Planus
- What is being tested?
- clobetasol propionate 0,05% ointment and hexaminolevulinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2011to Oct 2014
- Phase
- Phase 2/3
- 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
- Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.
- Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above
Who cannot join
- Current pelvic inflammatory disease, genital malignancy, or gynecological infection.
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
Read the detailed description
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
- Conditions
- Genital Lichen Planus
- Being tested
- clobetasol propionate 0,05% ointment, hexaminolevulinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobetasol propionate 0,05% ointmentDrug
Also called Dermovate 0.05% ointment
continuously daily treatment for 6 weeks
hexaminolevulinateDrug
one PDT treatment
| Study group | Role | What they receive |
|---|---|---|
| ELP active | Experimental | one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel Receives: Drug: hexaminolevulinate |
| topical steroids | Active comparator | treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks Receives: Drug: clobetasol propionate 0,05% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Measured: 6 weeks
Secondary outcomes (1)
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Lichen PlanusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Photocure
- Responsible party
- Principal investigator, Anne Lise Helgesen, Oslo University Hospital
- Investigators
- anne lise helgesen, md, Principal investigator, research fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282515
- Sponsor's protocol ID
- ALH ELP 2/10
- Status last verified
- Mar 2021
- First submitted
- 24 Jan 2011
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
- ClinicalTrials.gov ID
- NCT01282515
- Acronym / sponsor ID
- ALH ELP 2/10
- Conditions
- Genital Lichen Planus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Photocure
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Jan 2011 (estimated)
- 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.
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
Detailed description
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELP active | Experimental | Drug: hexaminolevulinateone PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel |
| topical steroids | Active comparator | Drug: clobetasol propionate 0,05% ointmenttreatment with clobetasol propionate 0.05% ointment used daily for 6 weeks |
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)
- Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.
- Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above
Key exclusion criteria (3 listed)
- Current pelvic inflammatory disease, genital malignancy, or gynecological infection.
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days
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 |
|---|---|---|
| clobetasol propionate 0,05% ointmentAlso: Dermovate 0.05% ointmentcontinuously daily treatment for 6 weeks | Drug | topical steroids |
| hexaminolevulinateone PDT treatment | Drug | ELP active |
Primary outcome
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Time frame: 6 weeks
1 secondary outcome
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Related trials for Genital Lichen Planus
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Enrolling by invitationObservational study
Vaginal Ecosystem and Network in the United States Study
Bacterial Vaginosis, Candidiasis
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 principal investigator
research fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing clobetasol propionate 0,05% ointment and hexaminolevulinate in people with Genital Lichen Planus, 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 3 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: finished, as of the sponsor's last update on 17 Mar 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment. (time frame: 6 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 17 Mar 2021.