Clinical trial NCT03457246: Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
Official title: Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lentigo
Hyperpigmentation
Keywords: solar lentigos
physical Hyperpigmentation therapies
cosmetic topical depigmenting product
topical Hyperpigmentation therapies
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intra-individual hand controlled trial (left/ right comparison)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos.
timeFrame: Assessed at 12 months versus baseline.
Secondary outcomes:
measure: Change over time of skin color homogeneity by blinded evaluation from standardized photos.
timeFrame: assessed at Day 0, 3 months, 6 months, and 9 months.
measure: Change over time of skin color homogeneity by clinical evaluation.
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months.
measure: Lentigos number by clinical evaluation
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Lentigos number by blinded count from standardized photos.
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Evaluation of lentigo Color versus healthy surrounding skin color by Colorimetry (L*, a*, b*)
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Pigment distribution of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Enlarged interpapillary spaces of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Intensity of papillary brightness of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Signs of inflammation in lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
timeFrame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
measure: Dynamic Physician Global Assessment (PGA)
timeFrame: assessed at 3 months, 6 months, 9 months and 12 months
measure: Overall efficacy assessed by the Subject
timeFrame: assessed at 3 months and 12 months
measure: Satisfaction regarding to the use of D-Pigment
timeFrame: assessed after 3 months of daily applications
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology - University of Modena and Reggio Emilia
name: Giovanni PELLACANI
role: PRINCIPAL_INVESTIGATOR
References: