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The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00705757
First Posted: June 26, 2008
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deepak P. Edward, Summa Health System
  Purpose
The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.

Condition Intervention Phase
Glaucoma Application Site Pigmentation Changes Drug: latanoprost Drug: bimatoprost Drug: travoprost Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation

Resource links provided by NLM:


Further study details as provided by Deepak P. Edward, Summa Health System:

Primary Outcome Measures:
  • The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. [ Time Frame: one year ]

    Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.

    Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement.



Enrollment: 89
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lumigan
Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
Drug: bimatoprost
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
Other Name: Lumigan 0.03%
Active Comparator: Xalatan
Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
Drug: latanoprost
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
Other Name: Xalatan 0.005%
Active Comparator: Travatan
Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
Drug: travoprost
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
Other Name: Travatan 0.004%

Detailed Description:
One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients recently diagnosed with primary open angle glaucoma or ocular hypertension
  • Caucasian and African American ethnicities
  • Male and Female
  • Age 30 and above

Exclusion Criteria:

  • A history of ocular medication use within the last 12 months
  • Inflammatory/ allergic skin diseases or dermatitis
  • presence of periocular hyperpigmented skin lesions
  • Systemic pigmentation disorders
  • Use of systemic drugs that can affect skin pigmentation
  • Visitation of tanning salons, or use of self tanning products
  • Pregnancy or patients planning to become pregnant in the near future
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705757


Locations
United States, Illinois
Arlington Eye Physicians
Arlington Heights, Illinois, United States, 60005
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Deepak P Edward, MD Summa Health System
Principal Investigator: Smajo Osmanovic, MD Arlington eye Associates
  More Information

Publications:
Albert DM, Gangnon RE, Zimbric ML, Damico CM, Fisher MR, Gleiser J, Grossniklaus HE, Green WR. A study of iridectomy histopathologic features of latanoprost- and non-latanoprost-treated patients. Arch Ophthalmol. 2004 Nov;122(11):1680-5.
Herndon LW, Robert D Williams, Wand M, Asrani S. Increased periocular pigmentation with ocular hypotensive lipid use in African Americans. Am J Ophthalmol. 2003 May;135(5):713-5.
Kook MS, Lee K. Increased eyelid pigmentation associated with use of latanoprost. Am J Ophthalmol. 2000 Jun;129(6):804-6.
Wand M, Ritch R, Isbey EK Jr, Zimmerman TJ. Latanoprost and periocular skin color changes. Arch Ophthalmol. 2001 Apr;119(4):614-5.
Kapur R, Osmanovic S, Toyran S, Edward DP. Bimatoprost-induced periocular skin hyperpigmentation: histopathological study. Arch Ophthalmol. 2005 Nov;123(11):1541-6.
Doshi M, Edward DP, Osmanovic S. Clinical course of bimatoprost-induced periocular skin changes in Caucasians. Ophthalmology. 2006 Nov;113(11):1961-7. Epub 2006 Aug 28.
Wistrand PJ, Stjernschantz J, Olsson K. The incidence and time-course of latanoprost-induced iridial pigmentation as a function of eye color. Surv Ophthalmol. 1997 Feb;41 Suppl 2:S129-38.
Alm A, Widengård I. Latanoprost: experience of 2-year treatment in Scandinavia. Acta Ophthalmol Scand. 2000 Feb;78(1):71-6.
McCarey BE, Kapik BM, Kane FE; Unoprostone Monotherapy Study Group. Low incidence of iris pigmentation and eyelash changes in 2 randomized clinical trials with unoprostone isopropyl 0.15%. Ophthalmology. 2004 Aug;111(8):1480-8.
Alm A, Schoenfelder J, McDermott J. A 5-year, multicenter, open-label, safety study of adjunctive latanoprost therapy for glaucoma. Arch Ophthalmol. 2004 Jul;122(7):957-65.
German EJ, Hurst MA, Wood D, Gilchrist J. A novel system for the objective classification of iris colour and its correlation with response to 1% tropicamide. Ophthalmic Physiol Opt. 1998 Mar;18(2):103-10.
Takamoto T, Schwartz B, Cantor LB, Hoop JS, Steffens T. Measurement of iris color using computerized image analysis. Curr Eye Res. 2001 Jun;22(6):412-9.
Melgosa M, Rivas MJ, Gómez L, Hita E. Towards a colorimetric characterization of the human iris. Ophthalmic Physiol Opt. 2000 May;20(3):252-60.
Elbaum M, Kopf AW, Rabinovitz HS, Langley RG, Kamino H, Mihm MC Jr, Sober AJ, Peck GL, Bogdan A, Gutkowicz-Krusin D, Greenebaum M, Keem S, Oliviero M, Wang S. Automatic differentiation of melanoma from melanocytic nevi with multispectral digital dermoscopy: a feasibility study. J Am Acad Dermatol. 2001 Feb;44(2):207-18.
Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. Review.
Andreassi L, Flori L. Practical applications of cutaneous colorimetry. Clin Dermatol. 1995 Jul-Aug;13(4):369-73.
Dornelles S, Goldim J, Cestari T. Determination of the minimal erythema dose and colorimetric measurements as indicators of skin sensitivity to UV-B radiation. Photochem Photobiol. 2004 Jun;79(6):540-4.
Draaijers LJ, Tempelman FR, Botman YA, Kreis RW, Middelkoop E, van Zuijlen PP. Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation? Burns. 2004 Mar;30(2):103-7.
Youn JI, Park JY, Jo SJ, Rim JH, Choe YB. Assessment of the usefulness of skin phototype and skin color as the parameter of cutaneous narrow band UVB sensitivity in psoriasis patients. Photodermatol Photoimmunol Photomed. 2003 Oct;19(5):261-4.
De Felice C, Flori ML, Pellegrino M, Toti P, Stanghellini E, Molinu A, Tosi P, Bagnoli F. Predictive value of skin color for illness severity in the high-risk newborn. Pediatr Res. 2002 Jan;51(1):100-5.
Tsai TF, Bowman PH, Jee SH, Maibach HI. Effects of glycolic acid on light-induced skin pigmentation in Asian and caucasian subjects. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):238-43. Erratum in: J Am Acad Dermatol 2000 Oct;43(4):609. Paul, BH [corrected to Bowman, PH].
Rubegni P, Cevenini G, Barbini P, Flori ML, Fimiani M, Andreassi L. Quantitative characterization and study of the relationship between constitutive-facultative skin color and phototype in Caucasians. Photochem Photobiol. 1999 Sep;70(3):303-7.
Park SB, Suh DH, Youn JI. A long-term time course of colorimetric evaluation of ultraviolet light-induced skin reactions. Clin Exp Dermatol. 1999 Jul;24(4):315-20.
Trujillo O, Vanezis P, Cermignani M. Photometric assessment of skin colour and lightness using a tristimulus colorimeter: reliability of inter and intra-investigator observations in healthy adult volunteers. Forensic Sci Int. 1996 Jul 31;81(1):1-10.
Maeda M, Kachi H, Matubara K, Mori S, Kitajima Y. Pigmentation abnormalities in systemic scleroderma examined by using a colorimeter (Choromo Meter CR-200). J Dermatol Sci. 1996 Mar;11(3):228-33.
Wu H, Wang H, Li H, Oshuaakey J, Xiao F, Ke Y, Xu H, Xiao J, Lu D, Parra E, Shriver M, Xiong M, Barton SA, Hewett-Emmett D, Liu W, Ji L. Skin reflectance in the Han Chinese and Tibetan populations. Hum Biol. 2001 Jun;73(3):461-6.
Van den Kerckhove E, Staes F, Flour M, Stappaerts K, Boeckx W. Reproducibility of repeated measurements on healthy skin with Minolta Chromameter CR-300. Skin Res Technol. 2001 Feb;7(1):56-9.
Takiwaki H, Miyaoka Y, Skrebova N, Kohno H, Arase S. Skin reflectance-spectra and colour-value dependency on measuring-head aperture area in ordinary reflectance spectrophotometry and tristimulus colourimetry. Skin Res Technol. 2002 May;8(2):94-7.
Lee JA, Osmanovic S, Viana MAG, Kapur R, Meghpara B, Edward DP.Objective measurement of Periocular Pigmentation. Invest. Ophthalmol. Vis Sci. 2006 47: E-Abstract 462

Responsible Party: Deepak P. Edward, PI, Summa Health System
ClinicalTrials.gov Identifier: NCT00705757     History of Changes
Other Study ID Numbers: Pfizer GA6111AX
First Submitted: June 24, 2008
First Posted: June 26, 2008
Results First Submitted: December 25, 2014
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: December 2015

Keywords provided by Deepak P. Edward, Summa Health System:
periocular skin pigmentation
Lumigan
Travatan
Xalatan
latanoprost
bimatoprost
travoprost

Additional relevant MeSH terms:
Ophthalmic Solutions
Latanoprost
Bimatoprost
Travoprost
Pharmaceutical Solutions
Antihypertensive Agents


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