Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy

February 28, 2018 updated by: Pierre Fabre Dermo Cosmetique
Pierre Fabre Dermo-Cosmétique has commercialized a cosmetic product (D-pigment rich texture) for treatment of hyperpigmentation. The aim of this study is to evaluate the efficacy of D-pigment after laser therapy, through its action on peri-lesional areas, in obtaining better cosmetic effect.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many studies have shown the efficacy of topical products such as hydroquinone, tretinoin, ascorbic and phytic acid... The combination of topical agents has shown better improvement of lentigos aspect. Many physical therapy such as chemical peels, cryosurgery, dermabrasion, and pigment-specific lasers show good results.

The combination of physical and topical therapies may be beneficial to patients. For example, the use of combination topical therapy may be used after cryotherapy as a maintenance therapy to diminish the risk of relapse. Laser therapy is very efficient on visible lesion, but not to prevent lesions apparition. A cosmetic topical depigmenting product may be a support of laser therapy, to prevent lentigos apparition in peri-lesional areas.

Furthermore, Post-inflammatory hyperpigmentation (PIH) is a common adverse effect seen with laser, occurring in approximately 35-40% of patients with Fitzpatrick skin types I-III. Another study related that 28% of study population has post-inflammatory hyperpigmentation. A cosmetic topical depigmenting product may be a support of laser therapy, to prevent possible laser side effect.

Pierre Fabre Dermo-Cosmétique has commercialized a cosmetic product (D-pigment rich texture) for treatment of hyperpigmentation. The aim of this study is to evaluate the efficacy of D-pigment as a support of a laser therapy, through its action on peri-lesional areas.

The expected effect is to show the efficacy of D-pigment in post laser long-term treatment, having a more homogenous skin colour on the D-pigment hand versus the moisturizer hand. The subjects will benefit from a strengthened follow-up by the investigator (one visit every 3 months). After the completion of the study, a complete hands laser treatment will be done for each subject and D-pigment tubes will be offered to the subjects for a 6 months application period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject consenting on the use of photos for scientific and commercial purposes,
  • Subject having signed his/her written informed consent.
  • Subject treated by laser therapy in the previous 15 to 30 days
  • Subject having 5 to 10 lentigos on the surface of each hands
  • Subject having lentigos graded 6 or more on the severity grading scale
  • Subject with same lentigo severity in each hand.

Exclusion Criteria:

  • Subject who has planned to stay for more than 15 days in an area with an important increase in sun exposure conditions compared to his/her usual place of residence,
  • Subject who has planned to sun expose himself/herself more than 7 days,
  • Women with childbearing potential
  • Participation to an other clinical trial in the previous month or during the study,
  • Subject who is not able to understand the information (for linguistic or psychiatric reasons), to give informed consent,
  • Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints during the study (daily product application during one year),
  • Subject who has forfeited her freedom by administrative or legal decision, or who is under guardianship.

Criteria related to pathologies:

  • Hyperpigmentation other than lentigos or other hypermelanosis (post-inflammatory laser or chemical melanosis) on the hands,
  • Diabetic subject,
  • Chronic or progressive disease which may interfere with the study in the opinion of the investigator,
  • Pathology, skin disorder or lesions other than lentigo (psoriasis, atopic dermatitis, mycose, intertrigo, sunburn…) at the dorsum of the hand which could interfere with the evaluation,
  • Systemic infectious pathology,
  • Hypersensitivity, allergy or intolerance to retinaldehyde or any component of the formulation.

Criteria related to treatments:

  • Treatment by depigmenting cosmetic products on the hands within 4 weeks prior to inclusion,
  • Treatment by depigmenting treatment containing hydroquinone or any depigmenting drug on the hands (e.g. topical retinoids, topical steroids, …) within 8 weeks prior to inclusion,
  • Previous treatment by chemical peels, dermabrasions on the hands within one year prior to inclusion,
  • Treatment by photosensitive agents within 8 weeks prior to inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: D-Pigment rich texture
Hand with 5 to 10 lentigos (graded 6 or more on the severity grading scale) treated by test product ( D-pigment rich texture).
Other: D-Pigment rich texture
Other Names:
  • Dermo-cosmetic product
Placebo Comparator: Hydrance optimale riche
Hand with 5 to 10 lentigos (graded 6 or more on the severity grading scale) treated by reference product (Hydrance optimale riche)
Other: Hydrance optimale riche
Other Names:
  • Dermo-cosmetic product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos.
Time Frame: Assessed at 12 months versus baseline.

Scoring homogeneity will be assessed through 2 Visual Analogue Scales. One VAS grades the surface affected by lentigo on observed area, no lentigo corresponding to 0 and area completely hidden by lentigo to 10.

The second VAS grades differences between lighter and darker skin of areas, same color skin corresponding to 0 and extremely dark lentigo to 10.

Sum of the two VAS (0 to 20) represents the homogeneity of the skin color Blinded evaluation.

During all the visits, an investigator will take photos. After visits, photos will be renamed and resampled. The investigator who will evaluate the parameter may be independent from that one who took photos.

Each parameter will be evaluated by the same person avoiding thus quotation bias. They will be evaluated on each area blinded from product applied and from time evaluated.

The appraiser will quote at the same time the pictures obtained for one subject, for one hand, at Baseline and at 12 months.
Assessed at 12 months versus baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change over time of skin color homogeneity by blinded evaluation from standardized photos.
Time Frame: assessed at Day 0, 3 months, 6 months, and 9 months.

Scoring homogeneity will be assessed through 2 Visual Analogue Scales. One VAS grades the surface affected by lentigo on observed area, no lentigo corresponding to 0 and area completely hidden by lentigo to 10.

The second VAS grades differences between lighter and darker skin of areas, same color skin corresponding to 0 and extremely dark lentigo to 10.

Sum of the two VAS (0 to 20) represents the homogeneity of the skin color Blinded evaluation.

During all the visits, an investigator will take photos. After visits, photos will be renamed and resampled. The investigator who will evaluate the parameter may be independent from that one who took photos.

Each parameter will be evaluated by the same person avoiding thus quotation bias. They will be evaluated on each area blinded from product applied and from time evaluated.

The appraiser will quote at the same time the pictures obtained for one subject, for one hand, at the different times evaluated for the study.
assessed at Day 0, 3 months, 6 months, and 9 months.
Change over time of skin color homogeneity by clinical evaluation.
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months.

An Investigator will grade the skin colour homogeneity by clinical evaluation through 2 Visual Analogue Scales.

One VAS grades the surface affected by lentigo on observed area, no lentigo corresponding to 0 and area completely hidden by lentigo to 10.

The second VAS grades differences between lighter and darker skin of areas, same color skin corresponding to 0 and extremely dark lentigo to 10.

Sum of the two VAS (0 to 20) represents the homogeneity of the skin color.
assessed at Day 0, 3 months, 6 months, 9 months and 12 months.
Lentigos number by clinical evaluation
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
At each visit the investigator will examine the subject, count the number of lentigos and report the number on the CRF.
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Lentigos number by blinded count from standardized photos.
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

During all the visits, an investigator will take photos. After visits, photos will be renamed and resampled. The investigator who will count the number of lentigos may be independent from that one who took photos.

The count will be performed by the same person avoiding thus quotation bias. Lentigos will be count on each area blinded from product applied and from time evaluated.

The appraiser will quote at the same time the pictures obtained for one subject, for one hand, at the different times evaluated for the study.
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Evaluation of lentigo Color versus healthy surrounding skin color by Colorimetry (L*, a*, b*)
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

Colorimetric measurements of the coloration are performed by a colorimeter. Skin color is characterized according to 3 components of the three-dimensional colorimetric space L *, a *, b *, where L* represents the brightness ( black / white axis), a* represent the redness ( green / red axis), b* represent the 'yellow' ( blue / yellow axis).

Four lentigos as "target lesions" will be selected. Colorimetric measurements will be performed on each and compared to those of healthy surrounding skin.
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Pigment distribution of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

Four lentigos as "target lesions" will be selected and imaged by RCM :

Pigment distribution will be evaluated through a 5 points scale. 0 = Absence of pigment on the study area

  1. < 10 %,
  2. = between 10-30%,
  3. = between 30-50%,
  4. > 50% of the study area covered by pigment
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Enlarged interpapillary spaces of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

Four lentigos as "target lesions" will be selected and imaged by RCM. Interpapillary spaces will be evaluated through a 4 points scale. 0 = Absence of interpapillary space

  1. < 10 %,
  2. = between 10-30%,
  3. = interpapillary space is between 30-50% of papillary size
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Intensity of papillary brightness of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

Four lentigos as "target lesions" will be selected and imaged by RCM. Interpapillary spaces will be evaluated through a 3 points scale.

1= low brightness 2 = medium 3= hight brightness
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Signs of inflammation in lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Time Frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months

Four lentigos as "target lesions" will be selected and imaged by RCM. inflammation signs will be evaluated through a 3 points scale. 0 = Absence of inflammation signs

  1. < 10 %,
  2. = between 10-30% of the study area covered by inflammation signs
assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Dynamic Physician Global Assessment (PGA)
Time Frame: assessed at 3 months, 6 months, 9 months and 12 months
For this parameter, four "target lesions" will be selected for the analysis: one previous treated by laser and one not treated by laser on each hand. The instrument's field of view will allow exploring parameters on the target lesions and the peri-lesional area.
assessed at 3 months, 6 months, 9 months and 12 months
Overall efficacy assessed by the Subject
Time Frame: assessed at 3 months and 12 months

The overall efficacy is defined through a 5 points scale. 0 = completely improved

  1. = mostly improved
  2. = slightly improved
  3. = no improvement
  4. = worse

The subjects will assess the overall efficacy on each global hand, on area treated by laser and area not treated by laser of each hand.

The efficacy assessed by the subjects will be compared at 3 and 12 months of product application between :

  • D-pigment hand versus moisturizer hand
  • area treated by laser on D-pigment hand versus area treated by laser on moisturizer hand
  • area not treated by laser on D-pigment versus area not treated by laser on moisturizer hand
assessed at 3 months and 12 months
Satisfaction regarding to the use of D-Pigment
Time Frame: assessed after 3 months of daily applications

The satisfaction regarding to the use of D-pigment (conditions of use, organoleptic properties, effects...) will be assessed by the subject through a questionnaire The overall satisfaction will be assessed by the Subject through a 5 points scale.

  1. = Much pleased
  2. = Pleased
  3. = Fairly pleased
  4. = Unpleased
  5. = Much Unpleased
assessed after 3 months of daily applications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Fabre Dermo Cosmetique

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giovanni PELLACANI, Department of Dermatology - University of Modena and Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RV4280A2012607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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