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Solar Lentigines Treatment With the Triple Combination Cream

Primary Purpose

Lentigo

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Triple combination cream
Tretinoin 0.05%
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lentigo focused on measuring lentigo, hydroquinone, tretinoin, fluocinolone acetonide

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontificia Universidad Católica de Chile

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triple combination cream

Arm Description

The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.

Outcomes

Primary Outcome Measures

Target lesion pigmentation becomes equal or slightly darker than the surrounding skin

Secondary Outcome Measures

Improvement in physician's global assessment

Full Information

First Posted
September 10, 2009
Last Updated
September 10, 2009
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00975312
Brief Title
Solar Lentigines Treatment With the Triple Combination Cream
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lentigo
Keywords
lentigo, hydroquinone, tretinoin, fluocinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple combination cream
Arm Type
Experimental
Arm Description
The triple combination cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) was applied on the whole back of one hand.
Intervention Type
Drug
Intervention Name(s)
Triple combination cream
Other Intervention Name(s)
Tri-luma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tretinoin 0.05%
Other Intervention Name(s)
Retacnyl
Intervention Description
Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.
Primary Outcome Measure Information:
Title
Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in physician's global assessment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William A Romero, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilia M Zegpi, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Study Chair
Facility Information:
Facility Name
Pontificia Universidad Católica de Chile
City
Santiago
ZIP/Postal Code
6904413
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
10688717
Citation
Fleischer AB Jr, Schwartzel EH, Colby SI, Altman DJ. The combination of 2% 4-hydroxyanisole (Mequinol) and 0.01% tretinoin is effective in improving the appearance of solar lentigines and related hyperpigmented lesions in two double-blind multicenter clinical studies. J Am Acad Dermatol. 2000 Mar;42(3):459-67. doi: 10.1016/s0190-9622(00)90219-6.
Results Reference
background
PubMed Identifier
17177746
Citation
Draelos ZD. The combination of 2% 4-hydroxyanisole (mequinol) and 0.01% tretinoin effectively improves the appearance of solar lentigines in ethnic groups. J Cosmet Dermatol. 2006 Sep;5(3):239-44. doi: 10.1111/j.1473-2165.2006.00260.x.
Results Reference
background
PubMed Identifier
1899343
Citation
Palumbo A, d'Ischia M, Misuraca G, Prota G. Mechanism of inhibition of melanogenesis by hydroquinone. Biochim Biophys Acta. 1991 Jan 23;1073(1):85-90. doi: 10.1016/0304-4165(91)90186-k.
Results Reference
background
PubMed Identifier
12941090
Citation
Petit L, Pierard GE. Analytic quantification of solar lentigines lightening by a 2% hydroquinone-cyclodextrin formulation. J Eur Acad Dermatol Venereol. 2003 Sep;17(5):546-9. doi: 10.1046/j.1468-3083.2003.00808.x.
Results Reference
background
PubMed Identifier
2024983
Citation
Weinstein GD, Nigra TP, Pochi PE, Savin RC, Allan A, Benik K, Jeffes E, Lufrano L, Thorne EG. Topical tretinoin for treatment of photodamaged skin. A multicenter study. Arch Dermatol. 1991 May;127(5):659-65.
Results Reference
background
PubMed Identifier
17097400
Citation
Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dermatol. 2006 Dec;55(6):1048-65. doi: 10.1016/j.jaad.2006.02.009. Epub 2006 Sep 28.
Results Reference
background
PubMed Identifier
16631968
Citation
Rendon M, Berneburg M, Arellano I, Picardo M. Treatment of melasma. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S272-81. doi: 10.1016/j.jaad.2005.12.039.
Results Reference
background
PubMed Identifier
12889718
Citation
Taylor SC, Torok H, Jones T, Lowe N, Rich P, Tschen E, Menter A, Baumann L, Wieder JJ, Jarratt MM, Pariser D, Martin D, Weiss J, Shavin J, Ramirez N. Efficacy and safety of a new triple-combination agent for the treatment of facial melasma. Cutis. 2003 Jul;72(1):67-72.
Results Reference
background
PubMed Identifier
17348994
Citation
Ferreira Cestari T, Hassun K, Sittart A, de Lourdes Viegas M. A comparison of triple combination cream and hydroquinone 4% cream for the treatment of moderate to severe facial melasma. J Cosmet Dermatol. 2007 Mar;6(1):36-9. doi: 10.1111/j.1473-2165.2007.00288.x.
Results Reference
background
PubMed Identifier
16167418
Citation
Torok H, Taylor S, Baumann L, Jones T, Wieder J, Lowe N, Jarret M, Rich P, Pariser D, Tschen E, Martin D, Menter A, Weiss J. A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. J Drugs Dermatol. 2005 Sep-Oct;4(5):592-7.
Results Reference
background
PubMed Identifier
16631967
Citation
Ortonne JP, Pandya AG, Lui H, Hexsel D. Treatment of solar lentigines. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S262-71. doi: 10.1016/j.jaad.2005.12.043.
Results Reference
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Solar Lentigines Treatment With the Triple Combination Cream

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