| CTRI Number |
CTRI/2024/05/067215 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A detailed study of non infective skin diseases involving hands |
|
Scientific Title of Study
|
A prospective study on clinical, psychological, dermoscopic and dermatoglyphic characteristics of inflammatory hand dermatosis |
| Trial Acronym |
IHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhruvika Tiwari |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room 21 OPD BLOCK Department of Dermatology Venereology and Leprosy Kasturba Hospital Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9878933000 |
| Fax |
|
| Email |
dhruvikatiwari1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room 21 OPD BLOCK Department of Dermatology Venereology and Leprosy Kasturba Hospital Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448910972 |
| Fax |
|
| Email |
drsmithaprabhu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Prabhu S |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room 21 OPD BLOCK Department of Dermatology Venereology and Leprosy Kasturba Hospital Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448910972 |
| Fax |
|
| Email |
drsmithaprabhu@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhruvika Tiwari |
| Address |
Room number 21 Old OPD block Skin OPD Department of Dermatology Venereology and Leprosy Kasturba Hospital Manipal Udupi Karnataka India
Pin code 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhruvika Tiwari |
Kasturba Hospital |
Room number 21 Skin OPD Old OPD Block Kasturba Hospital Madhav Nagar Manipal Udupi Karnataka
Udupi
KARNATAKA |
9878933000
dhruvikatiwari1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, (2) ICD-10 Condition: L259||Unspecified contact dermatitis, unspecified cause, (3) ICD-10 Condition: L240||Irritant contact dermatitis due todetergents, (4) ICD-10 Condition: L408||Other psoriasis, (5) ICD-10 Condition: L241||Irritant contact dermatitis due tooils and greases, (6) ICD-10 Condition: L242||Irritant contact dermatitis due tosolvents, (7) ICD-10 Condition: L243||Irritant contact dermatitis due tocosmetics, (8) ICD-10 Condition: L244||Irritant contact dermatitis due todrugs in contact with skin, (9) ICD-10 Condition: L245||Irritant contact dermatitis due toother chemical products, (10) ICD-10 Condition: L246||Irritant contact dermatitis due tofood in contact with skin, (11) ICD-10 Condition: L247||Irritant contact dermatitis due toplants, except food, (12) ICD-10 Condition: L248||Irritant contact dermatitis due toother agents, (13) ICD-10 Condition: L249||Irritant contact dermatitis, unspecified cause, (14) ICD-10 Condition: L250||Unspecified contact dermatitis dueto cosmetics, (15) ICD-10 Condition: L251||Unspecified contact dermatitis dueto drugs in contact with skin, (16) ICD-10 Condition: L252||Unspecified contact dermatitis dueto dyes, (17) ICD-10 Condition: L253||Unspecified contact dermatitis dueto other chemical products, (18) ICD-10 Condition: L254||Unspecified contact dermatitis dueto food in contact with skin, (19) ICD-10 Condition: L255||Unspecified contact dermatitis dueto plants, except food, (20) ICD-10 Condition: L258||Unspecified contact dermatitis dueto other agents, (21) ICD-10 Condition: L26||Exfoliative dermatitis, (22) ICD-10 Condition: L230||Allergic contact dermatitis due tometals, (23) ICD-10 Condition: L231||Allergic contact dermatitis due toadhesives, (24) ICD-10 Condition: L232||Allergic contact dermatitis due tocosmetics, (25) ICD-10 Condition: L233||Allergic contact dermatitis due todrugs in contact with skin, (26) ICD-10 Condition: L234||Allergic contact dermatitis due todyes, (27) ICD-10 Condition: L235||Allergic contact dermatitis due toother chemical products, (28) ICD-10 Condition: L236||Allergic contact dermatitis due tofood in contact with the skin, (29) ICD-10 Condition: L237||Allergic contact dermatitis due toplants, except food, (30) ICD-10 Condition: L238||Allergic contact dermatitis due toother agents, (31) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, (32) ICD-10 Condition: L298||Other pruritus, (33) ICD-10 Condition: L403||Pustulosis palmaris et plantaris, (34) ICD-10 Condition: L409||Psoriasis, unspecified, (35) ICD-10 Condition: L402||Acrodermatitis continua, (36) ICD-10 Condition: L419||Parapsoriasis, unspecified, (37) ICD-10 Condition: L439||Lichen planus, unspecified, (38) ICD-10 Condition: L441||Lichen nitidus, (39) ICD-10 Condition: L448||Other specified papulosquamous disorders, (40) ICD-10 Condition: L449||Papulosquamous disorder, unspecified, (41) ICD-10 Condition: L60||Nail disorders, (42) ICD-10 Condition: L62||Nail disorders in diseases classified elsewhere, (43) ICD-10 Condition: L851||Acquired keratosis [keratoderma] palmaris et plantaris, (44) ICD-10 Condition: L852||Keratosis punctata (palmaris et plantaris), (45) ICD-10 Condition: L859||Epidermal thickening, unspecified, (46) ICD-10 Condition: L929||Granulomatous disorder of the skinand subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age group more than 18 years of Inflammatory hand dermatoses, who visit the dermatology outpatient department at Kasturba Hospital Manipal |
|
| ExclusionCriteria |
| Details |
Hand infections like Palmar Warts, Tinea manuum. Trauma and deformity of hand and fingers due to other causes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the characteristics and trends of inflammatory hand dermatoses, To assess the commonly affected occupation groups and work involved leading to such presentation and To analyse the impact, it has on the Quality of life of the patients
|
Standard of care follow up 2 to 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To look for the continuity and return of dermatoglyphics if attenuated, in next follow up
|
Standard of care follow up 2 to 4 weeks |
| To study the result of patch testing wherever indicated, in suspected allergic contact dermatitis |
Standard of care follow up 2 to 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective observational study on the inflammatory hand dermatoses with respect to clinical characteristics, dermoscopic findings, presence or attenuation of dermatoglyphics and impairment of quality in life. This study shall help in gaining insights about the spectrum of Inflammatory hand dermatosis, the factors affecting individuals suffering from the same and the impact it has on their physical and mental health. It shall also prove to be useful in gauging the degree of problems faced by individuals with acquired partial or complete adermatoglyphia for official purposes and social enrollment systems. It will also provide an idea whether dermatoglyphics can be easily restored with treatment in case of hand dermatoses. |