Clinical trial NCT01778179: A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
Official title: Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigines
Keywords: Lentigines
Cryotherapy
hyperpigmentation
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Solar Lentigines Count
timeFrame: up to 13 weeks
Secondary outcomes:
measure: Change From Baseline in Melanin Levels
timeFrame: Baseline and up to 13 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Brazilian Center for Studies in Dermatology
name: Doris Hexsel, MD
role: PRINCIPAL_INVESTIGATOR
References: