Solar Lentigines Treatment With the Triple Combination Cream
|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-lumaDrug: 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 ]
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|