Solar Lentigines Treatment With the Triple Combination Cream
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|ClinicalTrials.gov Identifier: NCT00975312|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : September 11, 2009
- 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.
* 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.
|Condition or disease||Intervention/treatment||Phase|
|Lentigo||Drug: Triple combination cream Drug: Tretinoin 0.05%||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||February 2009|
Experimental: Triple combination cream
The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.
Drug: Triple combination cream
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 Name: Tri-luma
Drug: Tretinoin 0.05%
Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.
Other Name: Retacnyl
- Target lesion pigmentation becomes equal or slightly darker than the surrounding skin [ Time Frame: 3 months ]
- Improvement in physician's global assessment [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975312
|Pontificia Universidad Católica de Chile|
|Santiago, Chile, 6904413|
|Principal Investigator:||William A Romero, MD||Pontificia Universidad Catolica de Chile|
|Study Chair:||Emilia M Zegpi, MD||Pontificia Universidad Catolica de Chile|