Vulvar Lichen Sclerosus
Conditions
Brief 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).
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.
Interventions
DRUGMC2-25 cream
Topical application
DRUGMC2-25 vehicle
Topical application
Sponsors
MC2 Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Parallel-group, Randomized, Double-blind
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) | 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MC2-25 Cream MC2-25 cream will be applied daily for 12 weeks
MC2-25 cream: Topical application | 16 |
| MC2-25-vehicle MC2-25 vehicle will be applied daily for 12 weeks
MC2-25 vehicle: Topical application | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | MC2-25 Cream | Total | MC2-25-vehicle |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 14.3 | 54.9 years STANDARD_DEVIATION 14.5 | 57.5 years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 32 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 32 Participants | 17 Participants |
| Region of Enrollment Denmark | 16 participants | 33 participants | 17 participants |
| Sex: Female, Male Female | 16 Participants | 33 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 11 / 15 | 15 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MC2-25 Cream | Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) | -4.0 units on a scale | Standard Error 0.8 |
| MC2-25-vehicle | Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) | -3.5 units on a scale | Standard Error 0.7 |