An interventional study of D-Pigment rich texture and Hydrance optimale riche in Lentigo and Hyperpigmentation, sponsored by Pierre Fabre Dermo Cosmetique. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Treatment
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.
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.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 40 is above the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Criteria related to pathologies:
Criteria related to treatments:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Dermo-cosmetic product
Also known as: Dermo-cosmetic product
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.
Time frame: Assessed at 12 months versus baseline.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 1. \< 10 %, 2. = between 10-30%, 3. = between 30-50%, 4. \> 50% of the study area covered by pigment
Time frame: 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 1. \< 10 %, 2. = between 10-30%, 3. = interpapillary space is between 30-50% of papillary size
Time frame: 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
Time frame: 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 1. \< 10 %, 2. = between 10-30% of the study area covered by inflammation signs
Time frame: 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.
Time frame: 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 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
Time frame: 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. 1. = Much pleased 2. = Pleased 3. = Fairly pleased 4. = Unpleased 5. = Much Unpleased
Time frame: assessed after 3 months of daily applications
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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