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)

Conditions

Vulvar lichen sclerosus (VLS)

Brief summary

Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.

Detailed description

Mean change in weekly mean Worst Pain Numeric Rating Score (WP-NRS) recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Change in Skindex-29 domains from baseline to week 12 for MC2-25 cream compared to MC2-25 vehicle.

Related papers

No related papers found yet.

Interventions

DRUGSame as test product

DRUGwithout activa substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.	—

Secondary

Measure	Time frame
Mean change in weekly mean Worst Pain Numeric Rating Score (WP-NRS) recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Change in Skindex-29 domains from baseline to week 12 for MC2-25 cream compared to MC2-25 vehicle.	—

Measure

Time frame

Mean change in weekly mean Worst Pain Numeric Rating Score (WP-NRS) recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥4-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WI-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Percentage of patients obtaining a ≥3-point improvement in weekly mean WP-NRS recorded in the patient’s diary from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle., Change in Skindex-29 domains from baseline to week 12 for MC2-25 cream compared to MC2-25 vehicle.

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Countries

Denmark

Outcome results

None listed