Page last updated: 2024-10-25

eflornithine and Keratosis, Actinic

eflornithine has been researched along with Keratosis, Actinic in 3 studies

Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.

Keratosis, Actinic: White or pink lesions on the arms, hands, face, or scalp that arise from sun-induced DNA DAMAGE to KERATINOCYTES in exposed areas. They are considered precursor lesions to superficial SQUAMOUS CELL CARCINOMA.

Research Excerpts

ExcerptRelevanceReference
"Prevention of nonmelanoma skin cancers remains a health priority due to high costs associated with this disease."2.82Phase IIB Randomized Study of Topical Difluoromethylornithine and Topical Diclofenac on Sun-Damaged Skin of the Forearm. ( Alberts, DS; Bartels, HG; Bartels, P; Bermudez, Y; Curiel-Lewandrowski, C; Einspahr, JG; Hu, C; Jeter, JM; Myrdal, PB; Stratton, SP; Warneke, JA; Yozwiak, M, 2016)
"With the incidence of nonmelanoma skin cancer on the rise, current prevention methods, such as the use of sunscreens, have yet to prove adequate to reverse this trend."1.37New agents for prevention of ultraviolet-induced nonmelanoma skin cancer. ( Athar, M; Camp, WL; Elmets, CA; Turnham, JW, 2011)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (33.33)29.6817
2010's2 (66.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Jeter, JM1
Curiel-Lewandrowski, C1
Stratton, SP1
Myrdal, PB1
Warneke, JA1
Einspahr, JG1
Bartels, HG1
Yozwiak, M2
Bermudez, Y1
Hu, C1
Bartels, P2
Alberts, DS2
Einspahr, J1
Saboda, K1
Liu, Y1
Brooks, C1
Bartels, H1
Camp, WL1
Turnham, JW1
Athar, M1
Elmets, CA1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm[NCT00601640]Phase 2184 participants (Actual)Interventional2007-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Histologic Score Diagnosis and Treatment Group

Change scores were computed by subtracting baseline histologic score from End of Study histologic score. Slides were formalin fixed. Histologic Score has been developed by this research group over the course of Grant (reference below). A standardized form captures data on the following criteria: basal or suprabasilar pleomorphism (atypia); inflammation; hyperkeratosis; parakeratosis. The atypia and inflammation were rated as: none (0), mild to moderate(1), and severe (2). The remaining criteria were rated as present (1) or absent (0). Histologic Scores were computed by adding together the codes for the histologic criteria. Higher scores reflected higher level of epidermal /dermal damage. (NCT00601640)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Eflornithine Hydrochloride0.33
Diclofenac Sodium0.26
Eflornithine Hydrochloride/Diclofenac Sodium0.64

Changes in Putrescine Over 3 Months

Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant. (NCT00601640)
Timeframe: 3 months

Interventionnmol/g skin (Mean)
Eflornithine Hydrochloride0.03
Diclofenac Sodium1.45
Eflornithine Hydrochloride/Diclofenac Sodium0.2

Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months

Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up. (NCT00601640)
Timeframe: 3 months

,,
Interventionparticipants (Number)
Burning and Stinging NoneBurning and stinging Mildburning and stinging ModerateBurning and Stinging SeverePruritis NonePruritis MildPruritis ModeratePruritis SevereRash, Redness. Erythema-NoneRash, Redness. Erythema-MildRash, Redness. Erythema-ModerateRash, Redness. Erythema-Severe
Diclofenac Sodium44800331261341080
Eflornithine Hydrochloride484004291046510
Eflornithine Hydrochloride/Diclofenac Sodium483104066040750

Trials

2 trials available for eflornithine and Keratosis, Actinic

ArticleYear
Phase IIB Randomized Study of Topical Difluoromethylornithine and Topical Diclofenac on Sun-Damaged Skin of the Forearm.
    Cancer prevention research (Philadelphia, Pa.), 2016, Volume: 9, Issue:2

    Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Anticarcinogenic Agents; Di

2016
Chemopreventive efficacy of topical difluoromethylornithine and/or triamcinolone in the treatment of actinic keratoses analyzed by karyometry.
    Analytical and quantitative cytology and histology, 2009, Volume: 31, Issue:6

    Topics: Administration, Topical; Aged; Antineoplastic Agents; Cell Nucleus; Dose-Response Relationship, Drug

2009

Other Studies

1 other study available for eflornithine and Keratosis, Actinic

ArticleYear
New agents for prevention of ultraviolet-induced nonmelanoma skin cancer.
    Seminars in cutaneous medicine and surgery, 2011, Volume: 30, Issue:1

    Topics: Anilides; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Carotenoids; Cell Transformation, Neoplas

2011