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

Primary Purpose

Actinic Keratosis, Actinic Lentigo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)
Sponsored by
NAOS Institute of Life Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Active serum on right

    Active serum on left

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the number of actinic lentigos on each hemiface and/or hemiskull (in men with baldness) treated with MRB serum 0.3% and placebo serum respectively. The counting of the lesions will be done by simple dermatological examination.
    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
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the number of actinic keratoses on each hemi-facial and/or hemi-cranial area (in men with baldness) treated with MRB 0.3% serum and placebo serum respectively. The counting of the lesions will be done by simple dermatological examination.
    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
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the grade of actinic keratosis defined by the AK-FAS (Actinic Keratosis Field Assessment Scale)
    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
    Assessment after 9 months and 12 months on the whole face and/or skull of the overall score determined by the sum of the total number of actinic lentigos and actinic keratoses on the whole face and/or skull. The counting of the two types of lesions will be done by simple dermatological examination.
    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
    Assessment after 9 months and 12 months on the whole face and/or skull of the number of actinic lentigos. The counting of the lesions will be done by simple dermatological examination.
    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 keratoses
    Assessment after 9 months and 12 months on the whole face and/or skull of the number of actinic keratoses. The counting of the lesions will be done by simple dermatological examination.
    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 the grade of actinic keratoses
    Assessment after 9 months and 12 months on the whole face and/or skull of the AK-FAS grade of actinic keratosis.
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic lentigos
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the number of actinic lentigos. The counting of the lesions will be done by simple dermatological examination.
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic lentigos and actinic keratoses
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the overall score determined by the sum of the total number of actinic lentigos and actinic keratoses on each hemi-face. The counting of the two types of lesions will be done by simple dermatological examination.
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic keratoses
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the number of actinic keratoses. The counting of the two types of lesions will be done by simple dermatological examination.
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull (in men with baldness) the effect of a MRB 0.3% serum on the grade of actinic keratoses
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the AK-FAS grade of actinic keratosis.
    To evaluate at each visit, the tolerance of MRB 0.3% serum versus a placebo serum
    Tolerance assessed at each visit. It will be assessed by the investigator during the visits using a 5-point scale (0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme) evaluating the following parameters: Erythema Desquamation Burning Pruritus Stretch A global score of tolerance will be calculated by the sum of the 5 parameters. The global score can vary between 0 and 20.
    To evaluate at 6 and 12 months from inclusion, the evolution of a lesioned area and an area of normal skin by confocal microscopy on each hemi-face/skull of 10 volunteer subjects.
    Confocal microscopy of a lesioned area and an area of normal skin: a study of the cells of the epidermis (keratinocytes), the dermis (fibroblasts) and the cellular infiltrate will be performed on a predefined area of each hemi-face/skull of 3 x3 cm at T0 (Inclusion) by Confocal Microscopy with a High Resolution Ultrasound (LC-OCT) and will be repeated at 6 and 12 months in 10 subjects The area will include at least one KA lesion, one lentigo lesion, and the peri-lesional healthy skin area.
    To evaluate the satisfaction of the subjects at 6 months (in hemi-face and/or skull), at 9 and 12 months (for the whole face and/or skull and in hemi-face and/or skull) regarding the use of a MRB 0.3 % serum
    Subject satisfaction will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull and in hemi-face and/or skull via a satisfaction questionnaire (abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9).
    To evaluate the satisfaction of the subjects regardind galenic at 6 months (in hemi-face and/or skull), at 9 and 12 months (for the whole face and/or skull and in hemi-face and/or skull) regarding the use of the applied serums
    Subject satisfaction will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull and in hemi-face and/or skull via a questionnaire on the galenic quality of the applied products (texture, ease of application, etc.).
    To evaluate the satisfaction of the investigator at 6, 9 and 12 months regarding the products used
    The investigator's satisfaction with the products will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull on a 5-point scale: = Very good effectiveness = Good effectiveness = Average effectiveness = Poor effectiveness = Not effective at all
    To evaluate subjects' compliance with serums application
    Product compliance will be assessed during the visits by weighing the tubes of product collected.

    Full Information

    First Posted
    November 24, 2021
    Last Updated
    December 9, 2021
    Sponsor
    NAOS Institute of Life Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05152407
    Brief Title
    MRB 0.3% Serum Effectiveness on 2 Early Clinical Markers of Photoinduced Cutaneous Aging: Actinic Lentigo and Actinic Keratosis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NAOS Institute of Life Science

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Skin aging is an extremely complex multifactorial process that disrupts the functions and structure of epidermal and dermal cells and extracellular matrix components and has multiple causes including extrinsic phenomena (UV radiation, exposure to pollution, etc.). It has important effects on the skin and is particularly apparent on the face. Indeed, sunlight, in particular ultraviolet light, is an important factor that contributes to cutaneous photoaging by inducing the photo-chronic generation of reactive oxygen species (ROS). Although skin has its own antioxidant system against ROS, these antioxidant defenses are not fully effective during sun exposure and weaken over time. Photoaging of the skin is characterized by the development of pigmentary disorders, such as actinic lentigos (AL), as well as benign skin tumors such as actinic keratosis (AK), both of which are target pathologies for this study. AL usually occur in the elderly. They are usually benign but can cause aesthetic problems. They are commonly seen on the hands but can appear on all areas of the body, especially on sun-exposed areas such as the face, back, arms, feet, shoulders and skull. There are different treatment approaches, including physical therapy such as laser therapy, pulsed light, chemical peeling, bleaching and cryotherapy or topical therapy such as hydroquinone (HQ). Although topical therapies are generally more time consuming compared to physical therapies, patients can control their own treatment and side effects can be decreased. AK is a very common skin lesion caused by chronic sun damage that typically measure less than 1 cm in diameter. KA is considered a premalignant epithelial skin lesion that may progress to squamous cell carcinoma. For this reason, all KA should be treated and clinical follow-up is recommended. The goals of treatment are: (i) to clinically eradicate obvious and subclinical lesions, (ii) to prevent their progression to EC, and (iii) to reduce the number of relapses and consequently increase the quality of life of patients. Medical treatment with antioxidant properties/actions that would allow the reduction of damaged cells seems to play a role in both the prevention and treatment of AL and KA (Nashan et al., 2013). In addition, a paper published in early 2020 highlighted a major role for carbonylation in the progression of this type of skin lesion (Tramutola et al., 2020). Based on these elements, we hypothesize that our cosmetic active ingredient - MRB - which has antioxidant activity and a specific and original chaperone effect giving it a strong capacity to fight against protein carbonylation- will be effective in the treatment of photo-induced signs of aging: keratoses and actinic lentigo, by a mechanism that acts on the oxidative stress pathway and the maintenance of cellular proteostasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Actinic Keratosis, Actinic Lentigo

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active serum on right
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Active serum on left
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)
    Intervention Description
    Serums will be topically applied twice a day (mornings and evenings).
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    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
    Description
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the number of actinic lentigos on each hemiface and/or hemiskull (in men with baldness) treated with MRB serum 0.3% and placebo serum respectively. The counting of the lesions will be done by simple dermatological examination.
    Time Frame
    1, 3 and 6 months
    Title
    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
    Description
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the number of actinic keratoses on each hemi-facial and/or hemi-cranial area (in men with baldness) treated with MRB 0.3% serum and placebo serum respectively. The counting of the lesions will be done by simple dermatological examination.
    Time Frame
    1, 3 and 6 months
    Title
    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
    Description
    Assessment at inclusion (T0), after 1 month, 3 months and 6 months of treatment of the grade of actinic keratosis defined by the AK-FAS (Actinic Keratosis Field Assessment Scale)
    Time Frame
    1, 3 and 6 months
    Title
    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
    Description
    Assessment after 9 months and 12 months on the whole face and/or skull of the overall score determined by the sum of the total number of actinic lentigos and actinic keratoses on the whole face and/or skull. The counting of the two types of lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    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
    Description
    Assessment after 9 months and 12 months on the whole face and/or skull of the number of actinic lentigos. The counting of the lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    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 keratoses
    Description
    Assessment after 9 months and 12 months on the whole face and/or skull of the number of actinic keratoses. The counting of the lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    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 the grade of actinic keratoses
    Description
    Assessment after 9 months and 12 months on the whole face and/or skull of the AK-FAS grade of actinic keratosis.
    Time Frame
    9 and 12 months
    Title
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic lentigos
    Description
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the number of actinic lentigos. The counting of the lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic lentigos and actinic keratoses
    Description
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the overall score determined by the sum of the total number of actinic lentigos and actinic keratoses on each hemi-face. The counting of the two types of lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull the effect of a MRB 0.3% serum on actinic keratoses
    Description
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the number of actinic keratoses. The counting of the two types of lesions will be done by simple dermatological examination.
    Time Frame
    9 and 12 months
    Title
    To evaluate in the long term, at 9 and 12 months, on each hemi-face and/or skull (in men with baldness) the effect of a MRB 0.3% serum on the grade of actinic keratoses
    Description
    Assessment after 9 months and 12 months on each hemi-face and/or hemi-skull (in men with baldness) of the AK-FAS grade of actinic keratosis.
    Time Frame
    9 and 12 months
    Title
    To evaluate at each visit, the tolerance of MRB 0.3% serum versus a placebo serum
    Description
    Tolerance assessed at each visit. It will be assessed by the investigator during the visits using a 5-point scale (0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme) evaluating the following parameters: Erythema Desquamation Burning Pruritus Stretch A global score of tolerance will be calculated by the sum of the 5 parameters. The global score can vary between 0 and 20.
    Time Frame
    1, 3, 6, 9 and 12 months
    Title
    To evaluate at 6 and 12 months from inclusion, the evolution of a lesioned area and an area of normal skin by confocal microscopy on each hemi-face/skull of 10 volunteer subjects.
    Description
    Confocal microscopy of a lesioned area and an area of normal skin: a study of the cells of the epidermis (keratinocytes), the dermis (fibroblasts) and the cellular infiltrate will be performed on a predefined area of each hemi-face/skull of 3 x3 cm at T0 (Inclusion) by Confocal Microscopy with a High Resolution Ultrasound (LC-OCT) and will be repeated at 6 and 12 months in 10 subjects The area will include at least one KA lesion, one lentigo lesion, and the peri-lesional healthy skin area.
    Time Frame
    6 and 12 months
    Title
    To evaluate the satisfaction of the subjects at 6 months (in hemi-face and/or skull), at 9 and 12 months (for the whole face and/or skull and in hemi-face and/or skull) regarding the use of a MRB 0.3 % serum
    Description
    Subject satisfaction will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull and in hemi-face and/or skull via a satisfaction questionnaire (abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9).
    Time Frame
    6, 9 and 12 months
    Title
    To evaluate the satisfaction of the subjects regardind galenic at 6 months (in hemi-face and/or skull), at 9 and 12 months (for the whole face and/or skull and in hemi-face and/or skull) regarding the use of the applied serums
    Description
    Subject satisfaction will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull and in hemi-face and/or skull via a questionnaire on the galenic quality of the applied products (texture, ease of application, etc.).
    Time Frame
    6, 9 and 12 months
    Title
    To evaluate the satisfaction of the investigator at 6, 9 and 12 months regarding the products used
    Description
    The investigator's satisfaction with the products will be evaluated at 6 months on each hemi-face and/or hemi-skull and at 9 and 12 months on the whole face and/or skull on a 5-point scale: = Very good effectiveness = Good effectiveness = Average effectiveness = Poor effectiveness = Not effective at all
    Time Frame
    6, 9 and 12 months
    Title
    To evaluate subjects' compliance with serums application
    Description
    Product compliance will be assessed during the visits by weighing the tubes of product collected.
    Time Frame
    1, 3, 6, 9 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23477760
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31906275
    Citation
    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.
    Results Reference
    background

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

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