Clinical trial NCT00975312: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lentigo
Keywords: lentigo
hydroquinone
tretinoin
fluocinolone acetonide
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2009-09-11
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Target lesion pigmentation becomes equal or slightly darker than the surrounding skin
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in physician's global assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: William A Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica de Chile
name: Emilia M Zegpi, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.