NCT03457246

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lentigo
• Hyperpigmentation

Interventions

Type	Name	Description
OTHER	D-Pigment rich texture
OTHER	Hydrance optimale riche

Timeline

• Start date: 2013-05-06
• Primary completion: 2014-06-10
• Completion: 2014-06-10
• First posted: 2018-03-07
• Last updated: 2018-03-07