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
  Purpose

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.

Condition Intervention Phase
Lentigo
Drug: Triple combination cream
Drug: Tretinoin 0.05%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Target lesion pigmentation becomes equal or slightly darker than the surrounding skin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in physician's global assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975312

Locations
Chile
Pontificia Universidad Católica de Chile
Santiago, Chile, 6904413
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Galderma Laboratories, L.P.
Investigators
Principal Investigator: William A Romero, MD Pontificia Universidad Catolica de Chile
Study Chair: Emilia M Zegpi, MD Pontificia Universidad Catolica de Chile
  More Information

Publications:

Responsible Party: William Andrés Romero, Pontificia Universidad Católica de Chile
ClinicalTrials.gov Identifier: NCT00975312     History of Changes
Other Study ID Numbers: LEN-TriC-001
Study First Received: September 10, 2009
Last Updated: September 10, 2009
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Pontificia Universidad Catolica de Chile:
lentigo
hydroquinone
tretinoin
fluocinolone acetonide

Additional relevant MeSH terms:
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Fluocinolone Acetonide
Hydroquinone
Tretinoin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 21, 2014