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

NCT03457246 | Completed

• 1 other identifier: RV4280A2012607
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lentigo; Hyperpigmentation

Keywords

solar lentigos; physical Hyperpigmentation therapies; cosmetic topical depigmenting product; topical Hyperpigmentation therapies

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 12 months versus baseline.

Secondary Outcomes (12)

• Change over time of skin color homogeneity by blinded evaluation from standardized photos.

  assessed at Day 0, 3 months, 6 months, and 9 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

• 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

Study Arms (2)

D-Pigment rich texture

EXPERIMENTAL

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

Hydrance optimale riche

PLACEBO COMPARATOR

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

Interventions

D-Pigment rich texture OTHER

Also known as: Dermo-cosmetic product

D-Pigment rich texture

Hydrance optimale riche OTHER

Also known as: Dermo-cosmetic product

Hydrance optimale riche

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

MeSH Terms

Conditions

Lentigo; Hyperpigmentation

Condition Hierarchy (Ancestors)

Melanosis; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giovanni PELLACANI

  Department of Dermatology - University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: intra-individual hand controlled trial (left/ right comparison)

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 7, 2018
• Study Start: May 6, 2013
• Primary Completion: June 10, 2014
• Study Completion: June 10, 2014
• Last Updated: March 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share