Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: D-Pigment rich texture (Other)
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)
干预措施: Hydrance optimale riche (Other)
结局指标
主要结局
Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos.
时间窗: 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.
次要结局
- Lentigos number by blinded count from standardized photos.(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*)(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)(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)(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)(assessed at Day 0, 3 months, 6 months, 9 months and 12 months)
- Overall efficacy assessed by the Subject(assessed at 3 months and 12 months)
- Change over time of skin color homogeneity by clinical evaluation.(assessed at Day 0, 3 months, 6 months, 9 months and 12 months.)
- Lentigos number by clinical evaluation(assessed at Day 0, 3 months, 6 months, 9 months and 12 months)
- Change over time of skin color homogeneity by blinded evaluation from standardized photos.(assessed at Day 0, 3 months, 6 months, and 9 months.)
- Pigment distribution of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)(assessed at Day 0, 3 months, 6 months, 9 months and 12 months)
- Dynamic Physician Global Assessment (PGA)(assessed at 3 months, 6 months, 9 months and 12 months)
- Satisfaction regarding to the use of D-Pigment(assessed after 3 months of daily applications)