Hypopigmented SkinNCT04089475
Dermoscopy of Hypo-pigmented Lesions in Children
An observational study of Hypopigmented Skin, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hypopigmented Skin
- What is being tested?
- Dermoscope
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.
Who may be able to join
- All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.
Who cannot join
- Patients on topical or systemic treatment ( in the last 1 and 3 months , respectively) will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hypo-pigmented Skin Lesions in Children : Dermoscopic Evaluation
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.
Read the detailed description
Among the most common disorders of hypo-pigmentation in children are pityriasis alba, vitiligo, nevus depigmentosus, postinflammatory hypopigmentation and tinea versicolor ; while idiopathic guttate hypomelanosis and hypopigmented mycosis fungoides comes late.
Pityriasis alba : is a low-grade type of eczema/dermatitis mostly occurring in children and young adults , usually seen as dry, fine-scaled, pale patches on the face .
Vitiligo : is an acquired, autoimmune, idiopathic disorder characterized by circumscribed depigmented macules and patches with or without leukotrichia .
Nevus depigmentosus : is a localized hypopigmentation which most of the time is congenital. It is considered as a form of cutaneous mosaicism.
Postinflammatory hypopigmentation : is an acquired partial or total loss of skin pigmentation occurring after cutaneous inflammation. Many cutaneous inflammatory conditions lead to postinflammatory hypopigmentation in children as :Atopic dermatitis , Insect bite reactions, Psoriasis, Stevens-Johnson syndrome ….; Infections as Chickenpox, Impetigo …..; Cutaneous injuries from burns, irritants .All tend to induce postinflammatory hypopigmentation rather than hyperpigmentation .
Pityriasis versicolor or tinea versicolor : is a fungal infection of the superficial layer of skin caused by Malassezia yeasts. It is clinically characterized by hyperpigmented or hypopigmented, round to oval lesions covered with scales commonly found on the trunk, upper arms and face. Although it's common in adults but it can be seen in older group of children .
Idiopathic guttate hypomelanosis : is an acquired leukoderma found in all races; Its pathogenesis is unknown but may depend on various factors such as patient age and sun-exposure. Clinically, the lesions are porcelain-white macules, usually 2-6 mm in size, but sometimes they are larger. The borders are sharply defined, often angular and irregular with normal skin markings.
Mycosis fungoides, the most common primary cutaneous T-cell lymphoma: is a neoplastic disease characterized by classical non-infiltrated lesions (patches), plaques, tumors, and erythrodermic stages .It is considered a serious condition that has been seen before in children. Hypopigmented mycosis fungoides is one of its variants that is presented by hypopigmented-to-achromic lesions, sometimes with a vitiligo-like aspect.
In addition to clinical picture, Woods light examination and potassium hydroxide scrapping for scaly hypopigmented macules and histopathological evaluation are used to be the gold standard tests for diagnosis of those hypopigmented lesions in children.
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 . Recently, awareness and knowledge of dermoscopy have increased tremendously in many countries in diagnosis of many skin conditions .
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. New studies have documented dermoscopic features in vitiligo , While very few reports have documented the dermoscopic features of the other hypopigmented lesions.
- Conditions
- Hypopigmented Skin
- Being tested
- Dermoscope
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Almost 6 months after we start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hypopigmented SkinStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SNIsrael, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089475
- Sponsor's protocol ID
- DHLC
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Das JK, Gangopadhyay AK. Mycosis fungoides with unusual vitiligo-like presentation. Indian J Dermatol Venereol Leprol. 2004 Sep-Oct;70(5):304-6.
PubMed 17642645Al-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.
PubMed 31119026Kim 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.
PubMed 16908347Kim 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.
PubMed 20465639Lallas 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.
PubMed 24266695Miazek 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.
PubMed 26477326Pedrosa 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.
PubMed 24569116Thatte 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.
PubMed 25382506Yamashita 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.
PubMed 23197199Vachiramon 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.
PubMed 21671990Sori 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.
PubMed 22121275Argenziano 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.
PubMed 12734496
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo-pigmented Skin Lesions in Children : Dermoscopic Evaluation
- ClinicalTrials.gov ID
- NCT04089475
- Acronym / sponsor ID
- DHLC
- Conditions
- Hypopigmented Skin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Among the most common disorders of hypo-pigmentation in children are pityriasis alba, vitiligo, nevus depigmentosus, postinflammatory hypopigmentation and tinea versicolor ; while idiopathic guttate hypomelanosis and hypopigmented mycosis fungoides comes late.
Pityriasis alba : is a low-grade type of eczema/dermatitis mostly occurring in children and young adults , usually seen as dry, fine-scaled, pale patches on the face .
Vitiligo : is an acquired, autoimmune, idiopathic disorder characterized by circumscribed depigmented macules and patches with or without leukotrichia .
Nevus depigmentosus : is a localized hypopigmentation which most of the time is congenital. It is considered as a form of cutaneous mosaicism.
Postinflammatory hypopigmentation : is an acquired partial or total loss of skin pigmentation occurring after cutaneous inflammation. Many cutaneous inflammatory conditions lead to postinflammatory hypopigmentation in children as :Atopic dermatitis , Insect bite reactions, Psoriasis, Stevens-Johnson syndrome ….; Infections as Chickenpox, Impetigo …..; Cutaneous injuries from burns, irritants .All tend to induce postinflammatory hypopigmentation rather than hyperpigmentation .
Pityriasis versicolor or tinea versicolor : is a fungal infection of the superficial layer of skin caused by Malassezia yeasts. It is clinically characterized by hyperpigmented or hypopigmented, round to oval lesions covered with scales commonly found on the trunk, upper arms and face. Although it's common in adults but it can be seen in older group of children .
Idiopathic guttate hypomelanosis : is an acquired leukoderma found in all races; Its pathogenesis is unknown but may depend on various factors such as patient age and sun-exposure. Clinically, the lesions are porcelain-white macules, usually 2-6 mm in size, but sometimes they are larger. The borders are sharply defined, often angular and irregular with normal skin markings.
Mycosis fungoides, the most common primary cutaneous T-cell lymphoma: is a neoplastic disease characterized by classical non-infiltrated lesions (patches), plaques, tumors, and erythrodermic stages .It is considered a serious condition that has been seen before in children. Hypopigmented mycosis fungoides is one of its variants that is presented by hypopigmented-to-achromic lesions, sometimes with a vitiligo-like aspect.
In addition to clinical picture, Woods light examination and potassium hydroxide scrapping for scaly hypopigmented macules and histopathological evaluation are used to be the gold standard tests for diagnosis of those hypopigmented lesions in children.
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 . Recently, awareness and knowledge of dermoscopy have increased tremendously in many countries in diagnosis of many skin conditions .
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. New studies have documented dermoscopic features in vitiligo , While very few reports have documented the dermoscopic features of the other hypopigmented lesions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.
Key inclusion criteria (1 listed)
- All children up to (18) years old attending Assiut University Hospital complaining of hypopigmented skin lesions.
Key exclusion criteria (1 listed)
- Patients on topical or systemic treatment ( in the last 1 and 3 months , respectively) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermoscopeDermoscopy 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. | Device | – |
Primary outcome
To detect the sensitivity and specificity of the dermoscope in diagnosis of hypopigmented skin lesions in children
Time frame: Almost 6 months after we start
correlate the diagnosis of the hypopigmented lesions with the dermoscopic features and test the validity of the dermoscope in diagnosis .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 17642645Das JK, Gangopadhyay AK. Mycosis fungoides with unusual vitiligo-like presentation. Indian J Dermatol Venereol Leprol. 2004 Sep-Oct;70(5):304-6.
- Background: PubMed 31119026Al-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.
- Background: PubMed 16908347Kim 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.
- Background: PubMed 20465639Kim 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.
- Background: PubMed 24266695Lallas 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.
- Background: PubMed 26477326Miazek 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.
- Background: PubMed 24569116Pedrosa 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.
- Background: PubMed 25382506Thatte 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.
- Background: PubMed 23197199Yamashita 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.
- Background: PubMed 21671990Vachiramon 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.
- Background: PubMed 22121275Sori 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.
- Background: PubMed 12734496Argenziano 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.
Related trials for Hypopigmented Skin
Recruiting
Effect of Kendall Versus McKenzie Exercises in Patients With Upper Crossed Syndrome
Upper Crossed Syndrome
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypopigmented Skin, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hatem Zidan, MDT (00201003420217, hzma03@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect the sensitivity and specificity of the dermoscope in diagnosis of hypopigmented skin lesions in children (time frame: Almost 6 months after we start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089475, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.