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Note: This record shows only the 20 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.
Last refreshed on: 17 October 2012
Main ID:  NCT00975312
Date of registration: 10/09/2009
Primary sponsor: Pontificia Universidad Catolica de Chile
Public title: Solar Lentigines Treatment With the Triple Combination Cream
Scientific title: Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial.
Date of first enrolment: August 2008
Target sample size: 22
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Drug: Tretinoin 0.05%
Drug: Triple combination cream
Primary Outcome(s)
Target lesion pigmentation becomes equal or slightly darker than the surrounding skin [Time Frame: 3 months]
Secondary Outcome(s)
Improvement in physician's global assessment [Time Frame: 3 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Galderma Laboratories, L.P.
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