Solar Lentigines Treatment With the Triple Combination Cream

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Collaborator: Galderma Laboratories, L.P.
• Treatments: Fluocinolone Acetonide; Hydroquinone; Tretinoin

Criteria

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.