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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00975312 |
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Date of registration:
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10/09/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Solar Lentigines Treatment With the Triple Combination Cream
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Scientific title:
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Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial. |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00975312 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Emilia M Zegpi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Name:
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William A Romero, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects of both sexes of 30 - 80 years of age.
- Phototype II-V.
- Postmenopausal women of childbearing age or users of any contraception method with
negative pregnancy test (beta subunit chorionic gonadotropin in the blood) at
baseline and that maintain the contraceptive treatment during the investigation.
- Subjects with more than 10 solar lentigines on the back of each hand wich were no
treated in the last 6 months
Exclusion Criteria:
- Patients under 30 or over 80 years of age.
- Skin types I and VI.
- Less than 10 solar lentigines on the back of each hand.
- Patients who have received or are receiving any other treatment for lentigines of the
back of hands.
- Women of childbearing age without contraceptive therapy.
- Pregnancy or lactation.
- History of hypersensitivity to any component of the drugs.
- Simultaneous use of other topical skin lightening.
- Patient refusal to participate in the study.
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lentigo
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Intervention(s)
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Drug: Tretinoin 0.05%
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Drug: Triple combination cream
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Primary Outcome(s)
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Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
[Time Frame: 3 months]
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Secondary Outcome(s)
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Improvement in physician's global assessment
[Time Frame: 3 months]
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Secondary ID(s)
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LEN-TriC-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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