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Solar Lentigines Treatment With the Triple Combination Cream

NCT00975312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2009-09-11

No results posted yet for this study

Summary

Background

* Lentigines are usually the first sign of photoaging and may produce a significant impact on patients' quality of life.
* There is no a treatment of choice for this condition.
* Solar lentigines and melasma share similar physiopathologic characteristics.
* The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) has been effective and safe for the treatment of melasma and other hyperpigmented lesions.

Hypothesis

\* The TC cream will be effective and safe for the treatment of solar lentigines on the back of the hands.

Patients and methods

* 22 patients with solar lentigines were selected and their right hand or left hand were selected at random to be treated with either TC cream or tretinoin 0.05% cream once daily for up 12 weeks.
* Patients were instructed to apply both creams on the whole back of the hand and not only in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in both hands.
* Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of Improvement and a Subject's Self-Assessment questionnaire were collected for data analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.
* Statistical methods: The ordinally scaled efficacy measures underwent rank transformation and were analyzed by analysis of variance to test the null hypothesis of no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the XLSTAT 2009 software was used.

Conditions

  • Lentigo

Interventions

DRUG

Triple combination cream

The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand once daily for up 12 weeks.

DRUG

Tretinoin 0.05%

Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • William A Romero, MD · Pontificia Universidad Catolica de Chile

  • Emilia M Zegpi, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-11-30
Completion
2009-02-28

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975312 on ClinicalTrials.gov