Status:
COMPLETED
Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Lentigo
Hyperpigmentation
Eligibility:
All Genders
50+ years
Phase:
NA
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 la...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03457246
Start Date
May 6 2013
End Date
June 10 2014
Last Update
March 7 2018
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