Vulvar Lichen SclerosusPhase 2Orchid 1NCT06132919
Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)
A Phase 2 study testing MC2-25 cream in people with Vulvar Lichen Sclerosus, run by MC2 Therapeutics at 1 site in Denmark.
Trial summary
The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- MC2-25 cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2023to 8 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, of any race or ethnicity, who are ≥18 years of age at the time of screening.
- Able to understand the trial and willing to comply with trial requirements.
- Has provided written informed consent.
- Clinical diagnosis of VLS.
- Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis.
- First symptoms of VLS noticed by the patient at least 6 months before baseline.
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- At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit.
- At least moderate itch defined as average WI-NRS ≥4 at the Baseline visit.
- Women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline.
- Women of childbearing potential must agree to use a highly effective method of contraception.
Who cannot join
- Pregnant, breast feeding, or planning to become pregnant during the trial.
- Any (other than VLS) ongoing localized or systemic disease involving the vulvar region.
- Ongoing symptomatic Urinary Tract Infection.
- Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy.
- Any kind of ongoing cancer prior to the Baseline visit.
- Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial.
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- Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle.
- Start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the Baseline visit.
- Start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit.
- Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit.
- Start of new or change of menstrual care routines within 21 days prior to the Baseline visit.
- Use of emollients on the vulvar region within 3 days prior to the Baseline visit.
- Use of any topical treatment on the vulvar region, within 14 days prior to the Baseline visit.
- Use of any light therapy on the vulvar region, within 28 days prior to the Baseline visit.
- Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit.
- If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol.
- If previously randomized in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Group (2-arm), Randomised, Double-blind, 12-week Trial to Explore the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Women Diagnosed With Vulvar Lichen Sclerosus (VLS)
The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).
Read the detailed description
In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- MC2-25 cream, MC2-25 vehicle
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC2-25 creamDrug
Topical application
MC2-25 vehicleDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| MC2-25 cream | Experimental | MC2-25 cream will be applied daily for 12 weeks Receives: Drug: MC2-25 cream |
| MC2-25-vehicle | Experimental | MC2-25 vehicle will be applied daily for 12 weeks Receives: Drug: MC2-25 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
Mean change in weekly Worst Itch Numeric Rating score WI-NRS (as measured on a 11-point numeric rating scale from 0 - 10, where 0 represents no itch and 10 represents worst imaginal itch), calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start11 Oct 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- 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
- Parallel-group, Randomized, Double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- MC2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132919
- Sponsor's protocol ID
- MC2-25-C3
- Acronym
- Orchid 1
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2023
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group (2-arm), Randomised, Double-blind, 12-week Trial to Explore the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Women Diagnosed With Vulvar Lichen Sclerosus (VLS)
- ClinicalTrials.gov ID
- NCT06132919
- Acronym / sponsor ID
- Orchid 1 / MC2-25-C3
- Conditions
- Vulvar Lichen Sclerosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- MC2 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).
Detailed description
In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled.
Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.
The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, Randomized, Double-blind
| Arm | Type | Receives |
|---|---|---|
| MC2-25 cream | Experimental | Drug: MC2-25 creamMC2-25 cream will be applied daily for 12 weeks |
| MC2-25-vehicle | Experimental | Drug: MC2-25 vehicleMC2-25 vehicle will be applied daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women, of any race or ethnicity, who are ≥18 years of age at the time of screening.
- Able to understand the trial and willing to comply with trial requirements.
- Has provided written informed consent.
- Clinical diagnosis of VLS.
- Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis.
Key exclusion criteria (17 listed)
- Pregnant, breast feeding, or planning to become pregnant during the trial.
- Any (other than VLS) ongoing localized or systemic disease involving the vulvar region.
- Ongoing symptomatic Urinary Tract Infection.
- Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy.
- Any kind of ongoing cancer prior to the Baseline visit.
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 |
|---|---|---|
| MC2-25 creamTopical application | Drug | MC2-25 cream |
| MC2-25 vehicleTopical application | Drug | MC2-25-vehicle |
Primary outcome
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)
Time frame: 12 weeks
Mean change in weekly Worst Itch Numeric Rating score WI-NRS (as measured on a 11-point numeric rating scale from 0 - 10, where 0 represents no itch and 10 represents worst imaginal itch), calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MC2-25 cream in people with Vulvar Lichen Sclerosus, run by MC2 Therapeutics at 1 site in Denmark.
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 10 inclusion and 17 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 15 Oct 2025. 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 Denmark. 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 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?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) (time frame: 12 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 15 Oct 2025.