Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS) (Orchid 1)

September 26, 2025 updated by: MC2 Therapeutics

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Kolding, Denmark
        • MC2 Therapeutics study site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MC2-25 cream
MC2-25 cream will be applied daily for 12 weeks
Drug: MC2-25 cream
Topical application
Experimental: MC2-25-vehicle
MC2-25 vehicle will be applied daily for 12 weeks
Drug: MC2-25 vehicle
Topical application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MC2 Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC2-25-C3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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