NCT05152407|Unknown
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Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
35
0 countries
N/A
Study Start
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to evaluate effectiveness of a serum containing 0.3% of MRB, a cosmetic active ingredient, against actinic lentigo and actinic keratosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2023
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 24, 2021
Actual (reported)December 9, 2021
Actual (reported)January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To evaluate MRB 0.3% serum effectiveness after 6 months of treatment on 2 early clinical markers of photoinduced cutaneous aging: actinic lentigo and actinic keratosis
The primary endpoint will be the decrease at 6 months from baseline in the overall score determined by the sum of the total number of actinic lentigos and actinic keratoses on each hemi-face, one receiving MRB 0.3% serum and the other a placebo serum. For men with baldness, the evaluation could be performed on each hemi-skull and/or each hemi-face. The counting of the two types of lesions will be done by simple dermatological examination.
6 months
To evaluate 0.3% MRB serum effectiveness versus a placebo serum at inclusion, 1, 3 and 6 months of treatment on the evolution of actinic lentigos on each hemi- face and/or skull
1, 3 and 6 months
To evaluate 0.3% MRB serum effectiveness versus a placebo serum at inclusion, 1, 3 and 6 months of treatment on the evolution actinic keratoses on each hemi-face/skull
1, 3 and 6 months
To evaluate 0.3% MRB serum effectiveness versus a placebo serum at inclusion, 1, 3 and 6 months of treatment on the grade of actinic keratoses on each hemi-face/skull
1, 3 and 6 months
To evaluate in the long term, at 9 and 12 months, on the whole face and/or skull the effect of a MRB 0.3% serum on actinic lentigos and actinic keratoses
9 and 12 months
To evaluate in the long term, at 9 and 12 months, on the whole face and/or skull the effect of a MRB 0.3% serum on actinic lentigos
9 and 12 months
Right hemi face or skull will receive active serum (containing 0.3% MRB) / Left hemi face or skull will receive placebo serum for 6 months
Left hemi face or skull will receive active serum (containing 0.3% MRB) / Right hemi face or skull will receive placebo serum for 6 months
Serums will be topically applied twice a day (mornings and evenings).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nashan D, Meiss F, Muller M. Therapeutic strategies for actinic keratoses--a systematic review. Eur J Dermatol. 2013 Jan-Feb;23(1):14-32. doi: 10.1684/ejd.2013.1923.
Tramutola A, Falcucci S, Brocco U, Triani F, Lanzillotta C, Donati M, Panetta C, Luzi F, Iavarone F, Vincenzoni F, Castagnola M, Perluigi M, Di Domenico F, Marco F. Protein Oxidative Damage in UV-Related Skin Cancer and Dysplastic Lesions Contributes to Neoplastic Promotion and Progression. Cancers (Basel). 2020 Jan 1;12(1):110. doi: 10.3390/cancers12010110.
First Submitted
November 24, 2021
First Posted
December 9, 2021
Study Start
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses
Contact the study team to confirm eligibility.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 30, 2021
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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