MRB 0.3% Serum Effectiveness on 2 Early Clinical Markers of Photoinduced Cutaneous Aging: Actinic Lentigo and Actinic Keratosis

NCT05152407 | Unknown

• 2 other identifiers: 3020_ILS-MIRORU20ID RCB 2020-A02883-36
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Actinic Keratosis; Actinic Lentigo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• 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

Study Arms (2)

Active serum on right

EXPERIMENTAL

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

Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)

Active serum on left

EXPERIMENTAL

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

Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)

Interventions

Topical application of MRB 0.3% serum and placebo serum (hemi face or skull) OTHER

Serums will be topically applied twice a day (mornings and evenings).

Active serum on left; Active serum on right

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum of 5 actinic lentigos and 3 actinic keratoses of grade 1 or 2 on each hemi-face of the face and/or hemi-cranium (in men with baldness)
• Phototype I to III
• Patients with free, informed, written consent to participate in the study.
• Women unable to conceive or women of childbearing potential with a negative urine pregnancy test and using contraception

You may not qualify if:

• Subjects with less than 5 actinic lentigos or less than 3 actinic keratoses of grade 1 or 2 on each hemiface of the face and/or skull (for men with baldness)
• Phototype IV to VI
• Immunocompromised subject
• Subjects with a history of skin carcinoma in the treated areas
• Subjects using another active treatment for actinic keratoses or lentigos (or having used one in the past 3 months)
• Subjects unable to understand the information (due to language or psychiatric reasons)
• Subjects without social insurance
• Pregnant women
• Breastfeeding women
• Women of childbearing age without contraception
• Subjects under legal protection measures
• Subjects unable to express their consent
• Subjects under legal protection

Sponsors & Collaborators

• NAOS Institute of Life Science: lead

Related Publications (2)

• 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.

  PMID: 23477760 BACKGROUND

• 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.

  PMID: 31906275 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Project manager

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share