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A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT01778179
First received: January 4, 2013
Last updated: January 25, 2013
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Solar Lentigines
 Drug: Tri-luma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SAFETY AND EFFICACY OF A FIXED TRIPLE COMBINATION CREAM (FLUOCINOLONE ACETONIDE 0.01%, HYDROQUINONE 4%, TRETINOIN 0.05%) AS ADJUVANT TREATMENT OF SOLAR LENTIGINES WITH CRYOTHERAPY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • Solar lentigines count at each visit [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
    Solar lentigines count at each visit, up to 13 weeks


Secondary Outcome Measures:
  • Severity of Post-inflammatory hyperpigmentation [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
    scale of 4 points for post-inflammatory hyperpigmentation


Enrollment: 50
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1

Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks.Then, 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 - Visit ) - Topical antibiotic treatment phase (from week 2 up to Week 5 - visit 2 up to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.

- 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.

 Drug: 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.

Other Name: Tri-luma
Placebo Comparator: Group 2

Subjects (group 2) will be treated daily for their solar lentigines only with sumscreen for 2 weeks.Then, at week 2, all the subjects will have the solar lentigines will be treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (From week 2 up to Week 13 - Visit )

- Topical antibiotic treatment phase (from week 2 up to Week 5 - visit 2 up to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 lentiges 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778179

Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris Hexsel, MD Brazilian Center for Studies in Dermatology
  More Information

No publications provided

Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01778179     History of Changes
Other Study ID Numbers: 2012-03
Study First Received: January 4, 2013
Last Updated: January 25, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Brazilan Center for Studies in Dermatology:
Lentigines
Cryotherapy
hyperpigmentation

Additional relevant MeSH terms:
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013