Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
Sponsor study identifier
interventional
134
1 country
1
Study Start
November 23, 2021
Actual (reported)Primary Completion
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2021
Actual (reported)December 22, 2021
Actual (reported)February 8, 2022
Actual (reported)November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Global Subjective Score 75（GSS75） rate
GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable). GSS75 rate is the rate of patients achieving GSS75.
2 weeks after the final treatment
Recurrence rate
6 months, 12 months after the final treatment
Global Subjective Score 75（GSS75）
12 weeks after the final treatment
Global Objective Score（GOS）
2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Lichen Sclerosus Area （LSA）
2 weeks, 12 weeks, 6 months, 12months after the final treatment
Quality of Life（QOL）
2 weeks, 12 weeks, 6 months, 12 months after the final treatment
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm \*20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals.
Mometasone furoate cream (0.1%) for topical application, frequency: once daily, 5 days/week, for the first month; once every other day, for the second month; twice a week for the third month; the area of application should cover 0.5cm beyond the visible boundary of the lesion.
CO2 fraction laser
5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm).
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032, China
Guannan Zhu
Dermatology Derpartment of Xijing Hospital
First Submitted
December 22, 2021
First Posted
February 8, 2022
Study Start
November 23, 2021
Actual (reported)Primary Completion
November 30, 2023
Estimated (date passed)0.1% Mometasone furoate ointment is a potent steroid and has been proven to result as efficacious and well tolerated as clobetasol propionate which represent the recomended first-line treatment of vulvar lichen sclerosus.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 8, 2022
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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