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Completed

NCT Number: NCT01778179

A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

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.

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Key information

Conditions

Solar Lentigines Hyperpigmentation Lentigo Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Cryotherapy (CRY-AC3® device)

Procedure

Procedure performed at week 2.

Primary outcomes

  1. Solar Lentigines Count

    Time frame: up to 13 weeks

    Solar lentigines count up to 13 weeks

Secondary outcomes

  1. Change From Baseline in Melanin Levels

    Time frame: Baseline and up to 13 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hexsel Dermatology Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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