A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

NCT01778179 | Completed Results

• 1 other identifier: 2012-03
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solar Lentigines

Keywords

Lentigines; Cryotherapy; hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• Solar Lentigines Count

  Solar lentigines count up to 13 weeks

  up to 13 weeks

Secondary Outcomes (1)

• Change From Baseline in Melanin Levels

  Baseline and up to 13 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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; Procedure: Cryotherapy (CRY-AC3® device)

Group 2

PLACEBO COMPARATOR

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)

Interventions

Tri-luma 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.

Group 1

Cryotherapy (CRY-AC3® device) PROCEDURE

Procedure performed at week 2.

Group 1; Group 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

MeSH Terms

Conditions

Lentigo; Hyperpigmentation

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Melanosis; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Doris Hexsel
• Organization: Brazilian Center for Studies in Dermatology

doris@hexsel.com.br

+55 51 30262633

Study Officials

• Doris Hexsel, MD

  Brazilian Center for Studies in Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 29, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 14, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09