Trial Outcomes & Findings for Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS) (NCT NCT06132919)

Last Updated: 2025-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	MC2-25 Cream MC2-25 cream will be applied daily for 12 weeks MC2-25 cream: Topical application	MC2-25-vehicle MC2-25 vehicle will be applied daily for 12 weeks MC2-25 vehicle: Topical application
Overall Study STARTED	16	17
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MC2-25 Cream n=16 Participants MC2-25 cream will be applied daily for 12 weeks MC2-25 cream: Topical application	MC2-25-vehicle n=17 Participants MC2-25 vehicle will be applied daily for 12 weeks MC2-25 vehicle: Topical application	Total n=33 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 14.3 • n=5 Participants	57.5 years STANDARD_DEVIATION 14.5 • n=7 Participants	54.9 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Denmark	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	MC2-25 Cream n=16 Participants MC2-25 cream will be applied daily for 12 weeks MC2-25 cream: Topical application	MC2-25-vehicle n=17 Participants MC2-25 vehicle will be applied daily for 12 weeks MC2-25 vehicle: Topical application
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)	-4.0 units on a scale Standard Error 0.8	-3.5 units on a scale Standard Error 0.7

Adverse Events

MC2-25 Cream

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

MC2-25-vehicle

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

MC2 Therapeutics

Phone: +45 2018 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	MC2-25 Cream n=15 participants at risk MC2-25 cream will be applied daily for 12 weeks MC2-25 cream: Topical application	MC2-25-vehicle n=17 participants at risk MC2-25 vehicle will be applied daily for 12 weeks MC2-25 vehicle: Topical application
Gastrointestinal disorders Abdominal pain lower	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Abdominal pain upper	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Anal fissure	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Haemorrhoids	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Gastrointestinal disorders Nausea	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
General disorders Application site disconfort	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
General disorders Application site pain	26.7% 4/15 • Number of events 6 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	35.3% 6/17 • Number of events 7 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
General disorders Application site pruritus	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
General disorders Pyrexia	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Acarodermatitis	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Anal fungal infection	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Cystitis	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	11.8% 2/17 • Number of events 2 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Eye infection	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Herpes simplex	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Influenza	20.0% 3/15 • Number of events 3 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	17.6% 3/17 • Number of events 3 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Nasopharyngitis	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Pelvic inflammatory disease	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Pneumonia	13.3% 2/15 • Number of events 2 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Tinea infection	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Infections and infestations Urinary tract infection	20.0% 3/15 • Number of events 6 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Investigations Vitamin D decreased	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Metabolism and nutrition disorders Calcium deficiency	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	0.00% 0/17 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Nervous system disorders Migraine	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Psychiatric disorders Anxiety	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Renal and urinary disorders Dysuria	6.7% 1/15 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Renal and urinary disorders Incontinence	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Renal and urinary disorders Micturition urgency	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.
Renal and urinary disorders Pollakiuria	0.00% 0/15 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.	5.9% 1/17 • Number of events 1 • Adverse event information was collected from individual trial subjects from signature of the informed consent form and until the last trial visit, up to 18 weeks. Out of the 33 randomized subjects, 1 subject did not receive any treatment. The overall number of treated subjects, and thus included in the Adverse Event summary is 32 subjects (15 in the MC2-25 Cream group and 17 in the MC2-25-vehicle group.