Actinic KeratosisNCT05152407
MRB 0.3% Serum Effectiveness on 2 Early Clinical Markers of Photoinduced Cutaneous Aging: Actinic Lentigo and Actinic Keratosis
A study of Actinic Keratosis and Actinic Lentigo, run by NAOS Institute of Life Science.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Actinic Keratosis, Actinic Lentigo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Actinic Keratosis, Actinic Lentigo
- Being tested
- Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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 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.
Measured: 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 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.
Measured: 9 and 12 months
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.
Measured: 9 and 12 months
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.
Measured: 9 and 12 months
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.
Measured: 9 and 12 months
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.
Measured: 9 and 12 months
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.
Measured: 1, 3, 6, 9 and 12 months
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.
Measured: 6 and 12 months
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).
Measured: 6, 9 and 12 months
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.).
Measured: 6, 9 and 12 months
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
Measured: 6, 9 and 12 months
To evaluate subjects' compliance with serums application
Product compliance will be assessed during the visits by weighing the tubes of product collected.
Measured: 1, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NAOS Institute of Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, JULIE TISSERAND, NAOS Institute of Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152407
- Sponsor's protocol ID
- 3020_ILS-MIRORU20
- Other IDs
- ID RCB 2020-A02883-36
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23477760Tramutola 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.
PubMed 31906275
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05152407
- Acronym / sponsor ID
- 3020_ILS-MIRORU20
- Conditions
- Actinic Keratosis, Actinic Lentigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- NAOS Institute of Life ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active serum on right | Experimental | Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)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 |
| Active serum on left | Experimental | Other: Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical application of MRB 0.3% serum and placebo serum (hemi face or skull)Serums will be topically applied twice a day (mornings and evenings). | Other | Active serum on left, Active serum on right |
Primary outcome
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
Time frame: 6 months
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.
17 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 keratoses
Time frame: 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 the grade of actinic keratoses
Time frame: 9 and 12 months
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
Time frame: 9 and 12 months
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
Time frame: 9 and 12 months
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
Time frame: 9 and 12 months
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
Time frame: 9 and 12 months
To evaluate at each visit, the tolerance of MRB 0.3% serum versus a placebo serum
Time frame: 1, 3, 6, 9 and 12 months
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.
Time frame: 6 and 12 months
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
Time frame: 6, 9 and 12 months
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
Time frame: 6, 9 and 12 months
To evaluate the satisfaction of the investigator at 6, 9 and 12 months regarding the products used
Time frame: 6, 9 and 12 months
To evaluate subjects' compliance with serums application
Time frame: 1, 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Background: PubMed 23477760Nashan 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.
- Background: PubMed 31906275Tramutola 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Actinic Keratosis and Actinic Lentigo, run by NAOS Institute of Life Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.