A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

Brazilan Center for Studies in Dermatology

Status: Completed

Conditions: Solar Lentigines

Treatments: Drug: Tri-luma; Procedure: Cryotherapy (CRY-AC3® device)

Study type: Interventional

Funder types: Other

Identifiers

NCT01778179

2012-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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.

Treatment:

Drug: Tri-luma

Procedure: Cryotherapy (CRY-AC3® device)

Group 2

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Cryotherapy (CRY-AC3® device)