Efficacy of D-pigment dermocosmetic lightening product for solar lentigo lesions of the hand: A randomized controlled trial

Abstract

Solar lentigo, benign lesions which mostly appear on chronically, sun-exposed surfaces, are associated with ageing. Patients are increasingly requesting a more uniform skin texture, especially for hands. Treatment options include dermoabrasion, intense pulsed light, cryotherapy, peelings, and laser therapy. Topical compounds can be employed, in alternative or associated with dermatologic procedures. The current study was designed to evaluate solar lentigo hyperpigmentation, skin architecture and clinician and patient assessments comparing a dermocosmetic lightening product (active) with a moisturizing product (control) according to clinical, digital and subjective analyses in 72 lesions over 12-month follow up period. Statistically significant differences were observed between the lesions treated with the active compared to the control in terms of papillary brightness (p = 0.03) and contrast (p = 0.03), and in the limitation of dermal-epidermal junction destructuring (p = 0.03) according to dermal-epidermal junction destructuring score at Reflectance Confocal Microscopy. Luminance (p = 0.04) and redness (p = 0.03) were improved at color analysis, and physician and patient evaluations favored the active in efficacy and patient satisfaction investigations. The dermocosmetic lightening product utilized in the current study proved to be more effective, according to clinical, digital and subjective analyses in reducing lesion hyperpigmentation, stabilizing the lesion skin architecture and increasing patient satisfaction compared to the control in a cohort of 36 subjects, over a 12-month period. Beside demonstrating the efficacy of this topical lightening product, we propose a "destructuring score", which improves the robustness of solar lentigo's evaluation, and can be used in future studies to standardize the quantitative comparisons of different treatment options.

Conflict of interest statement

Author Ana Beatris Rossi was a full time employee of Pierre Fabre Dermocosmetics when the study was designed, conducted and analyzed. Authors Gwendal Josse, Jimmy Le Digabel, Emmanuel Questel are full time employee of Pierre Fabre dermocosmetics. Pierre Fabre Dermocosmetics provided funding for the study. Authors Gwendal Josse, Ana Beatris Rossi, Jimmy Le Digabel, Emmanuel Questel received support in the form of salary from this funder. Pierre Fabre Dermocosmetics had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We confirm that the declared competing interests does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. CONSORT flow chart of the study design.

Fig 2. Digital standardized photo.

Standardized photos were taken at T0 (baseline) with a plastic film placed over the hands to enable reproduction of the exact location of the target lesion during the follow-up.

Fig 3. Intensity of papillary brightness.

The intensity of papillary brightness is calculated through a numerical qualitative scale ranging from 1 to 3; 1: mild brightness resembling healthy skin; 2: intermediate brightness; 3: intense and sharp brightness of the papillary rim, due to a hyperpigmentation (melanin) of keratinocytes and melanocytes forming the rim.

Fig 4. Papillae features assessed for the “DEJ destructuring” score.

Evaluation of the most prevalent feature in each of the four quadrants of the image acquired (high left, high right, bottom left, bottom right).

Fig 5. Color analysis.

Seasonal effect of luminance of reference lentigines throughout the year.

Fig 6. RCM and papillary brightness intensity.

Papillary brightness intensity score at Reflectance Confocal Microscopy (RCM) over the 9 month follow-up period: dermocosmetic lightening product (solid line) and moisturizing product (dotted line).

Fig 7. RCM and papillary contrast.

Papillary contrast at Reflectance Confocal Microscopy (RCM) over the 9 month follow up period: dermocosmetic lightening product (solid line) and moisturizing product (dotted line).

Fig 8. RCM and DEJ.

DEJ destructuring score over the 9 month follow up period: dermocosmetic lightening product (solid line) and moisturizing product (dotted line).

Fig 9. Color analysis.

Color analysis for the lentigines luminance (Fig 9A) and the degree of redness (Fig 9B) for subjects treated with the dermocosmetic lightening product compared to moisturizing product; dermocosmetic lightening product (solid line) and moisturizing product (dotted line).

Fig 10. Physician global assessment.

Fig 10A: clinical evaluation according to the dynamic Physician Global Assessment (PGA) of the 72 target lesions, presented according to the topical product applied. Fig 10B: clinical images of the 3 categories of improvement observed according to the PGA scale; slight clearance (a: T0, a’: T12), moderate clearance (b: T0, b’: T12) and significant clearance (c: T0, c’:T12), respectively.

Fig 11. Patient evaluation.

Patient efficacy assessment as either slightly improved, mostly improved or not improved.