Solar Lentigines Treatment With the Triple Combination Cream

Phase 2

Completed

• Conditions: Lentigo
• Interventions: Drug: Triple combination cream; Drug: Tretinoin 0.05%

• Registration Number: NCT00975312
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Last Update Submitted: 2009-09-10
• Study First Posted: 2009-09-11
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple combination cream	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.
Triple combination cream	Tretinoin 0.05%	The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.

Primary Outcome Measures

Name	Time	Method
Target lesion pigmentation becomes equal or slightly darker than the surrounding skin	3 months

Secondary Outcome Measures

Name	Time	Method
Improvement in physician's global assessment	3 months

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Chile