The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye - Full Text View

Sponsored by:	Summa Health System
Information provided by:	Summa Health System
ClinicalTrials.gov Identifier:	NCT00705757

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 Periocular Skin Pigmentation Changes	Drug: Latanoprost Drug: Bimatoprost Drug: Travoprost	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost Travoprost Bimatoprost

U.S. FDA Resources

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

Further study details as provided by Summa Health System:

Primary Outcome Measures:

skin pigmentation changes [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients assigned to Lumigan	Drug: Bimatoprost 0.03% Bimatoprost ophthalmic sol. one drop qhs for one year
2: Active Comparator Patients assigned to Xalatan	Drug: Latanoprost 0.005% ophthalmic sol. one drop qhs for one year
3: Active Comparator Patients assigned to Travatan	Drug: Travoprost 0.004% ophthalmic sol., one drop qhs for one year

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

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705757

Contacts

Contact: Deepak P Edward, MD	330-375-3867	Edwardd@summa-health.org
Contact: Marianne A Wiest, BS	330-375-6655	Wiestm@summa-health.org

Locations

United States, Illinois
Arlington Eye Physicians	Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Smajo Osmanovic, MD 847-394-1414
Sub-Investigator: Smajo Osmanovic, MD
United States, Ohio
Summa Health System	Recruiting
Akron, Ohio, United States, 44304
Contact: Deepak P Edward, MD 330-375-3867
Contact: Marianne A Wiest, BS 330-375-6655 wiestm@summa-health.org
Principal Investigator: Deepak P Edward, MD

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. No abstract available.

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:	Summa health system ( Deepak P. Edward, MD )
Study ID Numbers:	Pfizer GA6111AX
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705757
Health Authority:	United States: Institutional Review Board

Keywords provided by Summa Health System:

periocular skin pigmentation
Lumigan
travatan
Xalatan

latanoprost
bimatoprost
travoprost

Study placed in the following topic categories:

Bimatoprost
Glaucoma
Eye Diseases
Latanoprost

Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009