HyperpigmentationNCT06320314
Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
A study testing tested product (2039125 03) in people with Hyperpigmentation, run by Cosmetique Active International at 1 site in Portugal.
Trial summary
The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- tested product (2039125 03)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Feb 2024to 22 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all phototypes
- only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
- female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study.
Who cannot join
- female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
- male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
- patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
- severe melasma, dermal melasma
- patient with facial pigmentary disorders other than those described in inclusion criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
PhDTrials Center
Lisbon
Pedro Pinto, +351 216034267 ext. 501, geral@phdtrials.com
About this study
Official title: Evaluation of the Efficacy and Tolerability of the Tested Formula 2039125 03 BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins: Melasma, Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo
The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
Read the detailed description
Hyperpigmentation is a common skin condition in which the colour of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure.
Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines.
This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with before/after comparisons.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
- Efficacy Analysis: in each group, the quantitative parameters are analyzed using a mixed-effect model. This model includes Time and baseline as fixed effects. Patient are added as random effect. The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment. Degrees of freedom for the comparisons are approximated by the Kenward-Roger method.
- Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively.
Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values.
Regarding the sample size determination, there was no formal calculation. A number of 20 patients in each group (i.e. 60 patients in total) was considered sufficient to meet the study objective.
- Conditions
- Hyperpigmentation
- Being tested
- tested product (2039125 03)
- Keywords
- facial hyperpigmentation, melasma, acne induced PIHP, solar lentigo
- Medical subject headings
- Hyperpigmentation, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tested product (2039125 03)Other
application twice a day of the tested product (in the morning and evening) and a sunscreen (in the morning and at midday) to the face for 3 months
| Study group | Role | What they receive |
|---|---|---|
| mild to moderate melasma | Experimental | adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2) Receives: Other: tested product (2039125 03) |
| mild to moderate acne induced PIHP | Experimental | adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e., less than 10 inflammatory lesions) Receives: Other: tested product (2039125 03) |
| solar lentigo | Experimental | adult patients suffering from solar lentigo with a pigmentation score > 5 Receives: Other: tested product (2039125 03) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (markedly darker than the surrounding normal skin)
Measured: from baseline to Day84
modified Melasma Area and Severity Index (mMASI) for patients with melasma
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)
Measured: from baseline to Day 84
Post-Acne Hyperpigmentation Index (PAHPI)
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 2 [< 3mm] to 8 [> 10mm], median lesion intensity (from 3 [slightly darker than surrounding skin] to 9 [significantly darker than surrounding skin] and number of lesions (from 1 [1-15] to 5 [> 60]. Total score ranges from 6 to 22.
Measured: from baseline to Day 84
Secondary outcomes (1)
colorimetry measurements
skin color is measured using the L*a*b* color space (L* represents lightness, a* its position between green and red, b* its position between blue and yellow).
Measured: from baseline to Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start19 Feb 2024
- Primary completion22 May 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Pinto, Principal investigator, PhDTrials center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320314
- Sponsor's protocol ID
- LRP23021-E serum
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerability of the Tested Formula 2039125 03 BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins: Melasma, Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo
- ClinicalTrials.gov ID
- NCT06320314
- Acronym / sponsor ID
- LRP23021-E serum
- Conditions
- Hyperpigmentation
- Keywords
- facial hyperpigmentation, melasma, acne induced PIHP, solar lentigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 20 Mar 2024 (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 objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
Detailed description
Hyperpigmentation is a common skin condition in which the colour of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure.
Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines.
This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with before/after comparisons.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
- Efficacy Analysis: in each group, the quantitative parameters are analyzed using a mixed-effect model. This model includes Time and baseline as fixed effects. Patient are added as random effect. The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment. Degrees of freedom for the comparisons are approximated by the Kenward-Roger method.
- Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively.
Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values.
Regarding the sample size determination, there was no formal calculation. A number of 20 patients in each group (i.e. 60 patients in total) was considered sufficient to meet the study objective.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild to moderate melasma | Experimental | Other: tested product (2039125 03)adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2) |
| mild to moderate acne induced PIHP | Experimental | Other: tested product (2039125 03)adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e., less than 10 inflammatory lesions) |
| solar lentigo | Experimental | Other: tested product (2039125 03)adult patients suffering from solar lentigo with a pigmentation score > 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all phototypes
- only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
- female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study.
Key exclusion criteria (5 listed)
- female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
- male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
- patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
- severe melasma, dermal melasma
- patient with facial pigmentary disorders other than those described in inclusion criteria
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 |
|---|---|---|
| tested product (2039125 03)application twice a day of the tested product (in the morning and evening) and a sunscreen (in the morning and at midday) to the face for 3 months | Other | mild to moderate acne induced PIHP, mild to moderate melasma, solar lentigo |
Primary outcome
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
Time frame: from baseline to Day84
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (markedly darker than the surrounding normal skin)
modified Melasma Area and Severity Index (mMASI) for patients with melasma
Time frame: from baseline to Day 84
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)
Post-Acne Hyperpigmentation Index (PAHPI)
Time frame: from baseline to Day 84
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 2 [< 3mm] to 8 [> 10mm], median lesion intensity (from 3 [slightly darker than surrounding skin] to 9 [significantly darker than surrounding skin] and number of lesions (from 1 [1-15] to 5 [> 60]. Total score ranges from 6 to 22.
1 secondary outcome
colorimetry measurements
Time frame: from baseline to Day84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Pedro Pinto principal investigator
PhDTrials center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tested product (2039125 03) in people with Hyperpigmentation, run by Cosmetique Active International at 1 site in Portugal.
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 3 inclusion and 5 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Pedro Pinto (+351 216034267 ext. 501, geral@phdtrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) (time frame: from baseline to Day84). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.