Solar Lentigines Treatment With the Triple Combination Cream
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
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.