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CompletedNCT00975312Updated Sep 11, 2009

Solar Lentigines Treatment With the Triple Combination Cream

A Phase 2 interventional study of Triple combination cream and Tretinoin 0.05% in Lentigo, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-09-11.

Sponsored by Pontificia Universidad Catolica de Chile · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Lentigo

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Keywords

  • lentigo
  • hydroquinone
  • tretinoin
  • fluocinolone acetonide
03

In context

Lentigo

28 studies on the registry are indexed under Lentigo; 2 are open to participants now.

This study's enrollment of 22 is below the median of 30 across 25 interventional studies indexed under Lentigo.

Browse Lentigo studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects of both sexes of 30 - 80 years of age.
  • Phototype II-V.
  • women of childbearing age or users of any 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

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 therapy.
  • Pregnancy or lactation.
  • History of to any component of the drugs.
  • Simultaneous use of other topical skin lightening.
  • Patient refusal to participate in the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
22 participants (actual)

Study arms

  • 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.

    Drug: Triple combination cream · Drug: Tretinoin 0.05%

Interventions

  • DrugTriple 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.

    Also known as: Tri-luma

  • Tretinoin 0.05% cream was applied on the whole back of the other hand once daily for up 12 weeks.

    Also known as: Retacnyl

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Improvement in physician's global assessment

    Time frame: 3 months

07

Study locations

1 site
  • Pontificia Universidad Católica de Chile
    Santiago, 6904413, Chile
08

References and documents

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. doi: 10.1016/s0190-9622(00)90219-6. PubMed 10688717 ↗
  • 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. PubMed 17177746 ↗
  • 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. PubMed 1899343 ↗
  • 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. PubMed 12941090 ↗
  • 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. PubMed 2024983 ↗
  • 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. PubMed 17097400 ↗
  • 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. PubMed 16631968 ↗
  • 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. PubMed 12889718 ↗
  • 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. PubMed 17348994 ↗
  • 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. PubMed 16167418 ↗
  • 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. PubMed 16631967 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00975312
Collaborators
Galderma R&D
First posted
Sep 11, 2009
Start date
Aug 2008
Primary completion
Nov 2008
Completion
Feb 2009
Last update
Sep 11, 2009

Study contacts

William A Romero, MD
principal investigator · Pontificia Universidad Catolica de Chile
Emilia M Zegpi, MD
study chair · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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