Solar Lentigines Treatment With the Triple Combination Cream

This study has been completed.
Sponsor:
Collaborator:
Galderma Laboratories, L.P.
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00975312
First received: September 10, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 10, 2009
September 10, 2009
August 2008
November 2008   (final data collection date for primary outcome measure)
Target lesion pigmentation becomes equal or slightly darker than the surrounding skin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Improvement in physician's global assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Solar Lentigines Treatment With the Triple Combination Cream
Solar Lentigines Treatment With the Triple Combination Cream (Hydroquinone 4%, Tretinoin 0.05%, and Fluocinolone Acetonide 0.01%). Randomized, Double Blind, Controlled Trial.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Lentigo
  • 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
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.
Interventions:
  • Drug: Triple combination cream
  • Drug: Tretinoin 0.05%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2009
November 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00975312
LEN-TriC-001
No
William Andrés Romero, Pontificia Universidad Católica de Chile
Pontificia Universidad Catolica de Chile
Galderma Laboratories, L.P.
Principal Investigator: William A Romero, MD Pontificia Universidad Catolica de Chile
Study Chair: Emilia M Zegpi, MD Pontificia Universidad Catolica de Chile
Pontificia Universidad Catolica de Chile
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP