Solar Lentigines Treatment With the Triple Combination Cream
Information source: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lentigo
Intervention: Triple combination cream (Drug); Tretinoin 0.05% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pontificia Universidad Catolica de Chile Official(s) and/or principal investigator(s): William A Romero, MD, Principal Investigator, Affiliation: Pontificia Universidad Catolica de Chile Emilia M Zegpi, MD, Study Chair, Affiliation: Pontificia Universidad Catolica de Chile
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
Secondary outcome: Improvement in physician's global assessment
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Pontificia Universidad Católica de Chile, Santiago 6904413, Chile
Additional Information
Related publications: 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. 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. 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. Petit L, Piérard GE. Analytic quantification of solar lentigines lightening by a 2% hydroquinone-cyclodextrin formulation. J Eur Acad Dermatol Venereol. 2003 Sep;17(5):546-9. 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. 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. Epub 2006 Sep 28. Review. Rendon M, Berneburg M, Arellano I, Picardo M. Treatment of melasma. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S272-81. Review. 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. 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. 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.
Starting date: August 2008
Last updated: September 10, 2009
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