NCT00975312

Solar Lentigines Treatment With the Triple Combination Cream

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2009-09-11
• Last updated: 2009-09-11

Locations

1 site across 1 country: Chile