A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

NCT ID: NCT01778179

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-12-31

Brief Summary

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

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.

Conditions

Solar Lentigines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

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.

Group Type: ACTIVE_COMPARATOR

Tri-luma

Intervention Type: DRUG

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.

Cryotherapy (CRY-AC3® device)

Intervention Type: PROCEDURE

Procedure performed at week 2.

Group 2

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.

Group Type: PLACEBO_COMPARATOR

Cryotherapy (CRY-AC3® device)

Intervention Type: PROCEDURE

Procedure performed at week 2.

Interventions

Tri-luma

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.

Intervention Type: DRUG

Cryotherapy (CRY-AC3® device)

Procedure performed at week 2.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Center for Studies in Dermatology

Other Identifiers

2012-03

Identifier Type: -

Identifier Source: org_study_id