LentigoNCT03457246
Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
A study testing D-Pigment rich texture and Hydrance optimale riche in people with Lentigo and Hyperpigmentation, run by Pierre Fabre Dermo Cosmetique.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lentigo, Hyperpigmentation
- What is being tested?
- D-Pigment rich texture and Hydrance optimale riche
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2013to 10 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 19Show fewer
- 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.
About this study
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.
Read the 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
- Being tested
- D-Pigment rich texture, Hydrance optimale riche
- Keywords
- solar lentigos, physical Hyperpigmentation therapies, cosmetic topical depigmenting product, topical Hyperpigmentation therapies
- Medical subject headings
- Lentigo, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Pigment rich textureOther
Also called Dermo-cosmetic product
Hydrance optimale richeOther
Also called Dermo-cosmetic product
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Other: Hydrance optimale riche |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 12 months versus baseline.
Secondary outcomes (12)
Change over time of skin color homogeneity 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 the different times evaluated for the study.
Measured: assessed at Day 0, 3 months, 6 months, and 9 months.
Change over time of skin color homogeneity by clinical evaluation.
An Investigator will grade the skin colour homogeneity by clinical evaluation 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.
Measured: assessed at Day 0, 3 months, 6 months, 9 months and 12 months.
Lentigos number by clinical evaluation
At each visit the investigator will examine the subject, count the number of lentigos and report the number on the CRF.
Measured: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Lentigos number by blinded count from standardized photos.
During all the visits, an investigator will take photos. After visits, photos will be renamed and resampled. The investigator who will count the number of lentigos may be independent from that one who took photos.
The count will be performed by the same person avoiding thus quotation bias. Lentigos will be count 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 the different times evaluated for the study.
Measured: 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*)
Colorimetric measurements of the coloration are performed by a colorimeter. Skin color is characterized according to 3 components of the three-dimensional colorimetric space L *, a *, b *, where L* represents the brightness ( black / white axis), a* represent the redness ( green / red axis), b* represent the 'yellow' ( blue / yellow axis).
Four lentigos as "target lesions" will be selected. Colorimetric measurements will be performed on each and compared to those of healthy surrounding skin.
Measured: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Pigment distribution of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Four lentigos as "target lesions" will be selected and imaged by RCM :
Pigment distribution will be evaluated through a 5 points scale. 0 = Absence of pigment on the study area
- < 10 %,
- = between 10-30%,
- = between 30-50%,
- > 50% of the study area covered by pigment
Measured: 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)
Four lentigos as "target lesions" will be selected and imaged by RCM. Interpapillary spaces will be evaluated through a 4 points scale. 0 = Absence of interpapillary space
- < 10 %,
- = between 10-30%,
- = interpapillary space is between 30-50% of papillary size
Measured: 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)
Four lentigos as "target lesions" will be selected and imaged by RCM. Interpapillary spaces will be evaluated through a 3 points scale.
1= low brightness 2 = medium 3= hight brightness
Measured: 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)
Four lentigos as "target lesions" will be selected and imaged by RCM. inflammation signs will be evaluated through a 3 points scale. 0 = Absence of inflammation signs
- < 10 %,
- = between 10-30% of the study area covered by inflammation signs
Measured: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Dynamic Physician Global Assessment (PGA)
For this parameter, four "target lesions" will be selected for the analysis: one previous treated by laser and one not treated by laser on each hand. The instrument's field of view will allow exploring parameters on the target lesions and the peri-lesional area.
Measured: assessed at 3 months, 6 months, 9 months and 12 months
Overall efficacy assessed by the Subject
The overall efficacy is defined through a 5 points scale. 0 = completely improved
- = mostly improved
- = slightly improved
- = no improvement
- = worse
The subjects will assess the overall efficacy on each global hand, on area treated by laser and area not treated by laser of each hand.
The efficacy assessed by the subjects will be compared at 3 and 12 months of product application between :
- D-pigment hand versus moisturizer hand
- area treated by laser on D-pigment hand versus area treated by laser on moisturizer hand
- area not treated by laser on D-pigment versus area not treated by laser on moisturizer hand
Measured: assessed at 3 months and 12 months
Satisfaction regarding to the use of D-Pigment
The satisfaction regarding to the use of D-pigment (conditions of use, organoleptic properties, effects...) will be assessed by the subject through a questionnaire The overall satisfaction will be assessed by the Subject through a 5 points scale.
- = Much pleased
- = Pleased
- = Fairly pleased
- = Unpleased
- = Much Unpleased
Measured: assessed after 3 months of daily applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start6 May 2013
- Primary completion10 Jun 2014
- Study completion10 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LentigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intra-individual hand controlled trial (left/ right comparison)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni PELLACANI, Principal investigator, Department of Dermatology - University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457246
- Sponsor's protocol ID
- RV4280A2012607
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy
- ClinicalTrials.gov ID
- NCT03457246
- Acronym / sponsor ID
- RV4280A2012607
- Conditions
- Lentigo, Hyperpigmentation
- Keywords
- solar lentigos, physical Hyperpigmentation therapies, cosmetic topical depigmenting product, topical Hyperpigmentation therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 6 May 2013 (actual)
- Primary completion
- 10 Jun 2014 (actual)
- Study completion
- 10 Jun 2014 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intra-individual hand controlled trial (left/ right comparison)
| Arm | Type | Receives |
|---|---|---|
| D-Pigment rich texture | Experimental | Other: D-Pigment rich textureHand with 5 to 10 lentigos (graded 6 or more on the severity grading scale) treated by test product ( D-pigment rich texture). |
| Hydrance optimale riche | Placebo comparator | Other: Hydrance optimale richeHand with 5 to 10 lentigos (graded 6 or more on the severity grading scale) treated by reference product (Hydrance optimale riche) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-Pigment rich textureAlso: Dermo-cosmetic product | Other | D-Pigment rich texture |
| Hydrance optimale richeAlso: Dermo-cosmetic product | Other | Hydrance optimale riche |
Primary outcome
Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos.
Time frame: 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.
12 secondary outcomes
Change over time of skin color homogeneity by blinded evaluation from standardized photos.
Time frame: assessed at Day 0, 3 months, 6 months, and 9 months.
Change over time of skin color homogeneity by clinical evaluation.
Time frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months.
Lentigos number by clinical evaluation
Time frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Lentigos number by blinded count from standardized photos.
Time frame: 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*)
Time frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Pigment distribution of lentigos assessed by In vivo Reflectance Confocal Microscopy (RCM)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: assessed at Day 0, 3 months, 6 months, 9 months and 12 months
Dynamic Physician Global Assessment (PGA)
Time frame: assessed at 3 months, 6 months, 9 months and 12 months
Overall efficacy assessed by the Subject
Time frame: assessed at 3 months and 12 months
Satisfaction regarding to the use of D-Pigment
Time frame: assessed after 3 months of daily applications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni PELLACANI principal investigator
Department of Dermatology - University of Modena and Reggio Emilia
Questions about this trial
What is this clinical trial studying?
A study testing D-Pigment rich texture and Hydrance optimale riche in people with Lentigo and Hyperpigmentation, run by Pierre Fabre Dermo Cosmetique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline skin color homogeneity at 12 months by blinded evaluation from standardized photos. (time frame: Assessed at 12 months versus baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.