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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lentigo, Hyperpigmentation

Intervention / Treatment
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* Other: D-Pigment rich texture
* Other: Hydrance optimale riche


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intra-individual hand controlled trial (left/ right comparison)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-Pigment rich texture<br>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<br> <br> * Other names: Dermo-cosmetic product;|
| Placebo Comparator: Hydrance optimale riche<br>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<br> <br> * Other names: Dermo-cosmetic product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos. | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of skin color homogeneity by blinded evaluation from standardized photos. | 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. | 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 | 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. | 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*) | 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) | 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 < 10 %, = between 10-30%, = between 30-50%, > 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) | 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 < 10 %, = between 10-30%, = 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) | 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) | 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 < 10 %, = 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) | 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 | The overall efficacy is defined through a 5 points scale. 0 = completely improved = mostly improved = slightly improved = no improvement = 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 | 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. = Much pleased = Pleased = Fairly pleased = Unpleased = Much Unpleased | assessed after 3 months of daily applications | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solar lentigos, physical Hyperpigmentation therapies, cosmetic topical depigmenting product, topical Hyperpigmentation therapies