Assessment of adapalene gel for the treatment of actinic keratoses and lentigines: A randomized trial

doi:10.1067/mjd.2003.451

Journal of the American Academy of Dermatology

Volume 49, Issue 1, July 2003, Pages 83-90

https://doi.org/10.1067/mjd.2003.451 Get rights and content

Abstract

Background: Adapalene is a synthetic retinoid with an established clinical efficacy against acne and good local tolerability. Its effectiveness in the treatment of photodamaged skin has not been studied. Objective: We sought to determine the safety and efficacy of adapalene gel in the treatment of actinic keratoses and solar lentigines. Methods: In a prospective, 2-center, randomized, controlled, investigator-masked, parallel-group study, 90 patients with actinic keratoses and solar lentigines were treated daily with either adapalene gel (0.1% or 0.3%) or its vehicle gel for 4 weeks, followed by twice-daily applications, if tolerated, for up to 9 months. Results: Of the 90 Caucasian patients (69 male, 21 female; mean age 63.1 years) who were enrolled into the study, 83 patients completed 9 months of treatment. With adapalene gel 0.1% and 0.3%, the mean number of actinic keratoses was reduced by 0.5 ± 0.9 (mean ± SE) and 2.5 ± 0.9, respectively. Whereas, with the vehicle gel, there was an increase of 1.5 ± 1.3 (P < .05). After 1 month of treatment, the patients who received adapalene had significant lightening of solar lentigines as compared with the patients who were treated with vehicle gel (P < .05). After 9 months, 57% and 59% of the patients had lighter lesions in the adapalene 0.1% and 0.3% groups, respectively, in comparison with only 36% in the vehicle group (P < .05). Histologic evaluations revealed improved cellular atypia and reduced epidermal melanin in adapalene-, as compared with vehicle-treated group. The differences, however, were not statistically significant. A retrospective evaluation of paired clinical photographs (before and after 9-month treatment) by 2 dermatologists who were treatment-blinded revealed significant improvement in wrinkles and other clinical features of photoaged skin with adapalene as compared with its vehicle. Conclusion: Adapalene gel 0.1% and 0.3% were well tolerated and improved actinic keratoses, solar lentigines, and other features of photodamaged skin. (J Am Acad Dermatol 2003;49:83-90.)

Section snippets

Patients and methods

A total of 90 consenting Caucasian patients were enrolled into this randomized, controlled, 2-center, investigator-masked, balanced parallel-group design study of 9 months duration. This study was reviewed and approved by each center's institutional review board before initiation.

Patients had to be between 18 and 85 years of age and have a minimum of 5 and a maximum of 25 visible actinic keratoses. There was no minimum number requirement for solar lentigines. The minimum size of individual

Results

A total of 90 patients, 45 from each center, were included in the study and 83 patients completed 9 months of treatment. All patients presented with actinic keratoses and approximately 75% of patients also had at least 1 solar lentigo. All of the patients were Caucasian, with the majority (79%) having skin phototypes I and II. Only 1 patient in the adapalene 0.3% group discontinued because of skin irritation and the other 6 patients discontinued because of non-treatment-related events. Patient

Discussion

Topical application of adapalene gel 0.1% and 0.3% was well tolerated and improved actinic keratoses and lentigines. In addition, retrospective evaluation of clinical photographs revealed that adapalene gel also improved signs of photoaging, particularly mottled hyperpigmentation and fine wrinkles, during a treatment period of 9 months' duration.

Adapalene gel use resulted in a modest reduction in the number of actinic keratosis in a dose-dependent manner, whereas vehicle gel led to an increase

Acknowledgements

The authors thank John T. Headington, MD, for histologic evaluation of biopsy specimens; Harrold Carter for medical photography; and Kristy Andrew for editorial assistance.

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^☆: Supported by Galderma Corp, Fort Worth, Texas.

^☆☆: Disclosure: Dr Kang has served as an ad hoc paid consultant to and Dr Griffiths is a paid consultant to Galderma Corporation.

^★: Reprint requests: Sewon Kang, MD, University of Michigan Medical Center, Department of Dermatology, 1910A Alfred Taubman Center, Ann Arbor, MI 48109-0314. E-mail: [email protected].

^★★: ^*Dr Griffiths is currently at the Dermatology Centre, The University of Manchester, Salford, Manchester, UK.

^♢: 0190-9622/2003/$30.00 + 0

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ReportsAssessment of adapalene gel for the treatment of actinic keratoses and lentigines: A randomized trial☆,☆☆,★,★★,♢

Abstract

Section snippets

Patients and methods

Results

Discussion

Acknowledgements

J Am Acad Dermatol

Cancer Lett

J Am Acad Dermatol

J Am Acad Dermatol

J Am Acad Dermatol

J Am Acad Dermatol

J Biol Chem

Cell

J Invest Dermatol

Histopathology of the skin

The actinic keratosis: a perspective and update

Dermatol Surg

Actinic keratosis is squamous cell carcinoma

South Med J

Malignant potential of actinic keratoses and the controversy over treatment: a patient-oriented perspective

Arch Dermatol

Aging and photoaging of the skin: observations at the cellular and molecular level

Br J Dermatol

Reports
Assessment of adapalene gel for the treatment of actinic keratoses and lentigines: A randomized trial☆,☆☆,★,★★,♢