a)BRIEF RESUME OF THE INTENDED WORK: SERUM LEPTIN AND LIPID PROFILE IN SKIN TAGS

NEED FOR THE STUDY:

Skin tags are common benign lesions composed of loose fibrous tissue occurring mainly on the neck and major flexures as a soft round, pedunculated protrusion. They are also called as soft fibromas or acrochordons or fibroadipomas. Histologically the stroma has a loose connective tissue with dilated blood vessels resembling the papillary dermis with reduced or absent nerve tissue. 1

There have been reports in the literature that the presence of skin tags is associated with obesity and atherogenic profile. 2, 3, 4,5

Leptin is a 167 amino acid protein, a product of obese gene(ob), produced mainly by the adipocytes.6 Leptin levels are directly proportional to the fat mass.6 It is involved in the regulation of appetite and energy expenditure. Leptin receptors are produced abundantly in the brain and also in the peripheral tissue.7,8

It has been shown that the mechanism for skin tag formation is that the cells residing In epidermis and dermis posses leptin receptors 9,10 and that leptin has the ability to stimulate growth and proliferation of epidermal and dermal cells.11,12 The mitogenic effect of leptin on keratinocytes has been demonstrated during healing by in vivo studies. 9Leptin role has also been reported in cancer cells.13 It is therefore considered as a new growth factor.14,15

It is intended to make an observational study in our clinical set up regarding the association of dyslipidemia with skin tags. Thus help in the follow up by considering skin tags as a useful sign for the risk factor of cardiovascular complication.

REVIEW OF LITERATURE:

The 1st report describing the association of skin tags with atherogenic lipid profile was by M.A. Crook(2000)2

Frank et al, 11 in 2000 investigated the proliferative effect of leptin on the cutaneouskeratinocytes in rodents. Moreover, a direct proliferative effect of leptin on mouse and human keratinocytes was showed by Goren et al,10 in 2003. Also Stallmeyeret all, 9 2001 showed the importance of leptin as a mitogenic factor in skin repair and also topically administered leptin improved re epithelisation.

Erdogan et al, 8 2005 showed that skin tags may not be just innocent tumoral proliferation, thus a follow up may be beneficial.

In 2009, Ramazan Sari 3 showed that skin tags are cutaneous findings frequently associated with dyslipidemia and increased leptin levels but same yearCanan et al 14showed that there is positive correlation only between skin tags and lipid profile and not with leptin.

Omar safoury4 reported in two of his studies that there is a significant relationship between leptin and skin tags.

Erkek et al 5 2011 showed that skin tag correlation with serum leptin levels and that leptin resistance may be involved in the pathogenesis of skin tags

OBJECTIVES OF THE STUDY:

  1. To determine the serum lipid profile in skin tag patients.
  2. To assess serum leptin levels in skin tag patients.

b)MATERIALS AND METHODS:

SOURCE OF DATA:

The study will comprise cases of skin tags visiting theoutpatient department of Dermatology of Kempegowda Institute of Medical Sciences, Bangalore.

Sample size :

Total Number of Subjects : 80

Number of controls : 40

Number of cases : 40

Inclusion criteria: Cases include patients above 18yrs of age with 3and more skin tags, in both sexes.

Blood would be collected after an informed written consent.

Study duration: One and a half years

Study design: Comparative study

Sample design: Purposive sampling

Methodology:

Data for the study will be collected from all those who fulfill the inclusion and exclusion criteria on a purposive sampling using a pretested structured questionnaire after obtaining a written informed consent.

Statistical analysis:

The data collected will be analyzed statistically by computing descriptive statistics namely mean, standard deviation, range and any significant difference between the mean values of the study group and the control group will be tested using independent sample student t- test.

METHOD OF COLLECTION OF DATA:

Specimen collection:

Blood: 5 ml plain venous blood sample after overnight fasting of 12 hours will be obtained by venepuncture. This will be followed by centrifugation and then sample will be processed immediately.

Determinations:

  • Serum leptinwill be estimated by enzyme-linked immunosorbent assay (ELISA).
  • Serum cholesterol is estimated by enzymatic, colorimetric method.
  • Serum Triglyceride is estimated by enzymatic colorimetric test.
  • Serum HDL-Cholesterol estimated by homogenous enzymatic colorimetric test.
  • Serum VLDL-cholesterol is calculated according to the formula VLDL=TG/5.
  • Serum LDL-Cholesterol is estimated by homogenous enzymatic colorimetric assay.
  • Total Cholesterol/HDL-C and LDL-C/HDL-C ratios will be determined.

Does the study require any investigations or interventions to conduct on patients or other humans or animals? If so, Please describe briefly.

Study does not include any animal experiments. The following investigations will be carried out in cases of skin tags and healthy controls after taking informed written consent.

  1. Serum leptin
  2. Lipid profile
  • Serum Total cholesterol
  • Serum Triglycerides
  • Serum HDL cholesterol
  • Serum LDL cholesterol
  • Serum VLDL cholesterol
  • Total cholesterol/ HDL-C ratio
  • LDL-C/ HDL-C ratio

Has the Ethical clearance obtained from yourinstitution.

YES

c) LIST OF REFERENCES:

  1. Burns A, Breathnach s, Cox N, Griffith C E. Rooks textbook of dermatology. Blackwell publishing ; 36.42
  2. Crook M A. Skin tags and atherogenic lipid profile. J clin path 2000; 53:873 – 4
  3. Sari R, Akman A, Alpsoy E, Balchi M K. The metabolic profile in patients with skin tags. Clin exp Med 2010; 10:193 – 7
  4. El Safoury OS, Abdel Hay R M, Fawzy M H, Kadry D, Amin I M, Abu Zeid O M,Rashed L A. Skin tags, leptin, metabolic syndrome and change in the life style. Ind J Dermatol venereal leprol 2011; 77:577 – 601
  5. E Erkek, Kisa U, Bagci Y, Sezikli H. Leptin resistance and genetic predisposition as potential mechanism in the development of skin tags. Hong Kong J Dermatolvenerol 2011; 19 :108 – 114
  6. ZhengY,Proenca R, Maffei M, Barone M, Leopold L, Friedman J M. Positional cloning of the mouse gene and its human analogue.1994; 374:425 – 432
  7. Meier U, Gressner A M. Endocrine regulation of energy energymetabolism:review of pathobiochemical and clinical chemical aspects of leptin, ghrelin, adiponectin and resistin. Clinical chemistry 2004; 50(9):1511 – 1525
  8. Erdogan B S, Aktan S, Rota S, Evliyougli D. skin tags and atheroschlerotic risk factors. J Dermatol 2005; 32:371-5
  9. Stallmeyer B, Kampfer H, Podda M, Kaufmann R, Pfelschifter J, Frank S. A novel keratinocytemitogen: Regulation of leptin and its functional receptors in Skin repair. J invest dermatol 2001; 117:98 – 105
  10. Goren I, Pfelschifter J, Frank S. Determination of leptin signaling pathways in human and murinekeratinocyes. BiochemBiophys Rea Commun 2003;303:1080 – 5
  11. Frank S, Stallmeyer B, Kampfer H, Kolb N, Pfeilschifer J. Leptin enhances wound re epthilization and constitutes a direct function of leptin in skin repair. J clin invest 2000;106:501 – 9
  12. Wauter M, Considine R V, Vangaal L F. Human leptin- from adipocyte hormone to an endocrine mediator. Eur J endocrinology 2000;143:293 – 311
  13. Gorofalo C, Surmacz E. Leptin and Cancer. J Cellular Physio 2006; 207(1) :12 - 22
  14. G Sweeney. Leptin signaling. Cellular signaling 2002;14:655 – 663
  15. Gorpelioglu C, Erdal E, ArdicogluYetal. Serum leptin, atherogenic lipids and glucose levels in patients with skin tags. Indian J Dermatol 2009; 54(1) :20- 22