A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

Study Overview
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Brief Summary
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To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

Detailed Description
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To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.

Official Title
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Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.

Conditions
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Solar Lentigines

Intervention / Treatment
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* Drug: Tri-luma
* Procedure: Cryotherapy (CRY-AC3® device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol; Female and male subjects; Phototype II to IV; Subjects aged between 40 and 65 years; Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter History of post-inflammatory hyperpigmentation on body or face Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation; Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study; Availability of the subject throughout the study; Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study; Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol. Exclusion Criteria: Pregnant women or women intending to become pregnant in the following 5 months after screening; Lactation period; Subjects participating in other clinical trials; Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results; Subjects with neoplastic, muscular or neurological diseases; Subjects with inflammation or active infection in the area to be studied; Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol; Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (From Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. | Drug: Tri-luma<br>* Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks. Post-procedure phase (From week 2 up to Week 13 - Visit ) - Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.<br>Procedure: Cryotherapy (CRY-AC3® device)<br>* Procedure performed at week 2.<br>|
| Placebo Comparator: Group 2<br>Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13) Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. | Procedure: Cryotherapy (CRY-AC3® device)<br>* Procedure performed at week 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solar Lentigines Count | Solar lentigines count up to 13 weeks | up to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Melanin Levels | This assessment was made using a narrowband reﬂectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin. | Baseline and up to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lentigines, Cryotherapy, hyperpigmentation