Clinical trial · Interventional

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

MRB 0.3% Serum Effectiveness on 2 Early Clinical Markers of Photoinduced Cutaneous Aging: Actinic Lentigo and Actinic Keratosis A Single-center Clinical Study in Two Phases: First Phase: Randomized Double-blind Clinical Interventional Study Versus Placebo in Split Face or Split Skull Second Phase: Open-label Observational Clinical Study on the Entire Face or Skull

NCT05152407CI-TRIAL-00055726unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Actinic Keratosis	—	UNRESOLVED	—
Actinic Lentigo	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Active serum on right
description
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
interventionNames
1. Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)
type
EXPERIMENTAL
label
Active serum on left
description
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
interventionNames
1. Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)

Primary outcomes (1)

measure
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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years

Show eligibility criteria text

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

References

Publications (2)

BACKGROUNDNashan 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
BACKGROUNDTramutola 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