Clinical Trial: Solar Lentigines Treatment With the Triple Combination Cream

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 treatment

    Detailed Summary:
    Sponsor: Pontificia Universidad Catolica de Chile

    Current Primary Outcome: Target lesion pigmentation becomes equal or slightly darker than the surrounding skin [ Time Frame: 3 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Improvement in physician's global assessment [ Time Frame: 3 months ]

    Original Secondary Outcome: Same as current

    Information By: Pontificia Universidad Catolica de Chile

    Dates:
    Date Received: September 10, 2009
    Date Started: August 2008
    Date Completion:
    Last Updated: September 10, 2009
    Last Verified: September 2009