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Nelson C, Rigel D. Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation. J Clin Aesthet Dermatol. 2009;2(7):20-5
Nelson, C., & Rigel, D. (2009). Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation. The Journal of clinical and aesthetic dermatology, 2(7), 20-5.
Nelson, Christopher, and Rigel, Darrell. "Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation." The Journal of clinical and aesthetic dermatology vol. 2,7 (2009): 20-5.
Nelson C, Rigel D. Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation. J Clin Aesthet Dermatol. 2009 Jul;2(7):20-5. PMID: 20729966; PMCID: PMC2924138.
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J Clin Aesthet Dermatol. 2009 Jul;2(7):20-5.

Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation.

The Journal of clinical and aesthetic dermatology

Christopher Nelson, Darrell Rigel

Affiliations

  1. University of South Florida, Tampa, Florida.

PMID: 20729966 PMCID: PMC2924138

Abstract

OBJECTIVE: To evaluate the long-term effects of treatment with diclofenac sodium 3% in 2.5% hyaluronic acid gel on clinically diagnosed actinic keratosis lesions in well-defined skin areas.

DESIGN: A one-year extension of a Phase 4, single-arm, multicenter, open-label study was conducted. Patients in the original study received diclofenac sodium 3% gel twice daily for 90 days. The extension study consisted of a single evaluation approximately one year post-treatment.

SETTING: Five US centers.

PARTICIPANTS: Patients who had completed the initial treatment phase with no further treatment for actinic keratosis in the designated treatment blocks.

MEASUREMENTS: The primary endpoint was the proportion of patients achieving 75-percent clearance of actinic keratosis lesions at one-year follow up based on percent change from baseline in target lesion number score or cumulative lesion number score. Secondary endpoints were the proportion of patients achieving 100-percent actinic keratosis lesion clearance and change in investigator's global improvement index scores.

RESULTS: Eighty-one percent of patients reported no additional treatment for actinic keratosis lesions for one year after completing treatment with diclofenac sodium 3% gel. The proportion of patients with 75-percent clearance after one year was 91 percent (95% CI, 84-99%) for target lesions and 70 percent (95% CI, 57-83%) for cumulative lesions. The proportion of patients with 100-percent clearance at one year was 79 percent (95% CI, 67-90%) for target lesions and 30 percent (95% CI, 17-43%) for cumulative lesions. Investigator's global improvement index severity scores showed that the majority (96%) of patients improved from baseline after one year.

CONCLUSION: The efficacy of a single, 90-day course of diclofenac sodium 3% gel persisted in the majority of patients at one year. (J Clin Aesthetic Dermatol. 2009;2(7):20-25.).

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