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