Solar Lentigines Treatment With the Triple Combination Cream

Study Overview
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Brief Summary
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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.

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

Conditions
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Lentigo

Intervention / Treatment
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* Drug: Triple combination cream
* Drug: Tretinoin 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both sexes of 30 - 80 years of age. Phototype II-V. Postmenopausal women of childbearing age or users of any contraception method with negative pregnancy test (beta subunit chorionic gonadotropin in the blood) at baseline and that maintain the contraceptive treatment during the investigation. Subjects with more than 10 solar lentigines on the back of each hand wich were no treated in the last 6 months Exclusion Criteria: Patients under 30 or over 80 years of age. Skin types I and VI. Less than 10 solar lentigines on the back of each hand. Patients who have received or are receiving any other treatment for lentigines of the back of hands. Women of childbearing age without contraceptive therapy. Pregnancy or lactation. History of hypersensitivity to any component of the drugs. Simultaneous use of other topical skin lightening. Patient refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple combination cream<br>The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand. | Drug: Triple combination cream<br>* 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.<br>* Other names: Tri-luma;Drug: Tretinoin 0.05%<br>* Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.<br>* Other names: Retacnyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion pigmentation becomes equal or slightly darker than the surrounding skin |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in physician's global assessment |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lentigo, hydroquinone, tretinoin, fluocinolone acetonide