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Completed

NCT Number: NCT00975312

Solar Lentigines Treatment With the Triple Combination Cream

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.

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Key information

Conditions

Lentigo Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 6904413, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triple combination cream

Drug

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.

Other names: Tri-luma

Tretinoin 0.05%

Drug

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

Other names: Retacnyl

Primary outcomes

  1. Target lesion pigmentation becomes equal or slightly darker than the surrounding skin

    Time frame: 3 months

Secondary outcomes

  1. Improvement in physician's global assessment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Sep 11, 2009
Registry last updated
Sep 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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