NCT04089475

Brief Summary

Hypo-pigmented skin lesions in children are of great concern in the society. They cause anxiety among children and their parents due to the social stigma attached to these conditions especially in dark skinned children. Hypo pigmented skin lesions are commonly encountered in day-to-day practice, and they pose a diagnostic challenge for the clinician. They are one of the commonest complains in the dermatology clinics and generally share the same patient complaint which is characterized by the presence of hypo or depigmented patches or macules . Dermoscopy may be a helpful as a non-invasive tool in assisting the differential diagnosis of several hypopigmented macular lesions and has the potential to improve the diagnostic accuracy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 11, 2019

Last Update Submit

September 12, 2019

Conditions

Hypopigmented Skin

Outcome Measures

Primary Outcomes (1)

  • To detect the sensitivity and specificity of the dermoscope in diagnosis of hypopigmented skin lesions in children

    correlate the diagnosis of the hypopigmented lesions with the dermoscopic features and test the validity of the dermoscope in diagnosis .

    Almost 6 months after we start

Interventions

DermoscopeDEVICE

Dermoscopy is a noninvasive diagnostic tool that permits the visualization of morphological features that are not visible to the naked eye thus representing a link between macroscopic clinical dermatology and microscopic dermatopathology.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.

You may qualify if:

  • All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.

You may not qualify if:

  • Patients on topical or systemic treatment ( in the last 1 and 3 months , respectively) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Das JK, Gangopadhyay AK. Mycosis fungoides with unusual vitiligo-like presentation. Indian J Dermatol Venereol Leprol. 2004 Sep-Oct;70(5):304-6.

    PMID: 17642645BACKGROUND

  • Al-Refu K. Dermoscopy is a new diagnostic tool in diagnosis of common hypopigmented macular disease: A descriptive study. Dermatol Reports. 2018 Dec 21;11(1):7916. doi: 10.4081/dr.2018.7916. eCollection 2019 Jan 23.

    PMID: 31119026BACKGROUND

  • Kim SK, Kang HY, Lee ES, Kim YC. Clinical and histopathologic characteristics of nevus depigmentosus. J Am Acad Dermatol. 2006 Sep;55(3):423-8. doi: 10.1016/j.jaad.2006.04.053. Epub 2006 May 30.

    PMID: 16908347BACKGROUND

  • Kim SK, Kim EH, Kang HY, Lee ES, Sohn S, Kim YC. Comprehensive understanding of idiopathic guttate hypomelanosis: clinical and histopathological correlation. Int J Dermatol. 2010 Feb;49(2):162-6. doi: 10.1111/j.1365-4632.2009.04209.x.

    PMID: 20465639BACKGROUND

  • Lallas A, Giacomel J, Argenziano G, Garcia-Garcia B, Gonzalez-Fernandez D, Zalaudek I, Vazquez-Lopez F. Dermoscopy in general dermatology: practical tips for the clinician. Br J Dermatol. 2014 Mar;170(3):514-26. doi: 10.1111/bjd.12685.

    PMID: 24266695BACKGROUND

  • Miazek N, Michalek I, Pawlowska-Kisiel M, Olszewska M, Rudnicka L. Pityriasis Alba--Common Disease, Enigmatic Entity: Up-to-Date Review of the Literature. Pediatr Dermatol. 2015 Nov-Dec;32(6):786-91. doi: 10.1111/pde.12683. Epub 2015 Oct 19.

    PMID: 26477326BACKGROUND

  • Pedrosa AF, Lisboa C, Goncalves Rodrigues A. Malassezia infections: a medical conundrum. J Am Acad Dermatol. 2014 Jul;71(1):170-6. doi: 10.1016/j.jaad.2013.12.022. Epub 2014 Feb 22.

    PMID: 24569116BACKGROUND

  • Thatte SS, Khopkar US. The utility of dermoscopy in the diagnosis of evolving lesions of vitiligo. Indian J Dermatol Venereol Leprol. 2014 Nov-Dec;80(6):505-8. doi: 10.4103/0378-6323.144144.

    PMID: 25382506BACKGROUND

  • Yamashita T, Abbade LP, Marques ME, Marques SA. Mycosis fungoides and Sezary syndrome: clinical, histopathological and immunohistochemical review and update. An Bras Dermatol. 2012 Nov-Dec;87(6):817-28; quiz 829-30. doi: 10.1590/s0365-05962012000600001.

    PMID: 23197199BACKGROUND

  • Vachiramon V, Thadanipon K. Postinflammatory hypopigmentation. Clin Exp Dermatol. 2011 Oct;36(7):708-14. doi: 10.1111/j.1365-2230.2011.04088.x. Epub 2011 Jun 14.

    PMID: 21671990BACKGROUND

  • Sori T, Nath AK, Thappa DM, Jaisankar TJ. Hypopigmentary disorders in children in South India. Indian J Dermatol. 2011 Sep-Oct;56(5):546-9. doi: 10.4103/0019-5154.87152.

    PMID: 22121275BACKGROUND

  • Argenziano G, Soyer HP, Chimenti S, Talamini R, Corona R, Sera F, Binder M, Cerroni L, De Rosa G, Ferrara G, Hofmann-Wellenhof R, Landthaler M, Menzies SW, Pehamberger H, Piccolo D, Rabinovitz HS, Schiffner R, Staibano S, Stolz W, Bartenjev I, Blum A, Braun R, Cabo H, Carli P, De Giorgi V, Fleming MG, Grichnik JM, Grin CM, Halpern AC, Johr R, Katz B, Kenet RO, Kittler H, Kreusch J, Malvehy J, Mazzocchetti G, Oliviero M, Ozdemir F, Peris K, Perotti R, Perusquia A, Pizzichetta MA, Puig S, Rao B, Rubegni P, Saida T, Scalvenzi M, Seidenari S, Stanganelli I, Tanaka M, Westerhoff K, Wolf IH, Braun-Falco O, Kerl H, Nishikawa T, Wolff K, Kopf AW. Dermoscopy of pigmented skin lesions: results of a consensus meeting via the Internet. J Am Acad Dermatol. 2003 May;48(5):679-93. doi: 10.1067/mjd.2003.281.

    PMID: 12734496BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hatem Zidan, MDT

CONTACT

00201003420217hzma03@yahoo.com

Radwa Bakr, MDT

CONTACT

00201119988115radwabakr2011@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 13, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

September 13, 2019

Record last verified: 2019-09