CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Triple combination cream +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00975312
NCT00975312Phase 2Completed

Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial.

Pontificia Universidad Catolica de Chile·interventional·Posted Sep 11, 2009·Updated Sep 11, 2009

In Brief

A Phase 2 clinical trial evaluating Triple combination cream and Tretinoin 0.05% for Lentigo. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLentigo
CountriesChile
CollaboratorsGalderma R&D

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2009
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.8 years ago

Interventions

Triple combination creamdrug

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.

Tretinoin 0.05%drug

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