| CTRI Number |
CTRI/2021/09/036294 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a topically applied contact sensitiser in the treatment of patchy hair loss |
|
Scientific Title of Study
|
Effect of Diphenylcyclopropenone in Alopecia areata
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anza Khader |
| Designation |
Associate Professor |
| Affiliation |
Government medical college,kozhikode |
| Address |
Department of dermatology Government medical college Kozhikode
MASKAN,5/1986B, Rajiv Nagar Colony,PO Puthiyara -673004
Kozhikode
KERALA
673008
India |
| Phone |
09846082254 |
| Fax |
|
| Email |
anzashaan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anza Khader |
| Designation |
Associate Professor |
| Affiliation |
Government medical college,kozhikode |
| Address |
Department of dermatology
Medical college
Kozhikode
MASKAN,5/1986B,Rajiv Nagar Colony,PO Puthiyara,673004
Kozhikode
KERALA
673008
India |
| Phone |
09846082254 |
| Fax |
|
| Email |
anzashaan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anza Khader |
| Designation |
Associate Professor |
| Affiliation |
Government medical college,kozhikode |
| Address |
Department of dermatology Government medical college Kozhikode
MASKAN,5/1986B, Rajiv Nagar Colony,PO Puthiyara,673004
Kozhikode
KERALA
673008
India |
| Phone |
09846082254 |
| Fax |
|
| Email |
anzashaan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college Kozhikode |
| Address |
Government medical college ,Kozhikode |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anza Khader |
Government medical college,kozhikode |
Department of dermatology
Kozhikode
KERALA |
9846082254
anzashaan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Topical diphenylcyclopropenone |
After written informed consent all patients will undergo sensitization with a 2% solution of DPCP applied to an area of 5× 5 cm on lateral aspect of thigh . Two weeks later, 0.0001% DPCP is applied on to one side of the scalp and gradually the concentration is increased every week, until a mild erythema or pruritus occurs. The maintanence concentration will be the maximum level which produce erythema with or without pruritus for about 48 hours after application. Patients will be instructed to avoid direct sun exposure of the scalp and not to wash the scalp for 48 hours after each application. The opposite half of the scalp will serve as a control to rule out possible spontaneous remission. Once hair re-growth occur on the treated side, DPCP will be applied on the other side of scalp.
Outcome
Therapeutic response will be assessed as no response (0-10%hair growth),minimal response (regrowth of 50% of the scalp hair) moderate response ( 50-90% ) complete response (regrowth of 90 % of the scalp hair).
Other Variables
Presence of pruritus, erythema, erosions ,lymph node enlargement ,pigmentary changes like hyperpigmentation or depigmentation will be noted during each visit .
Follow up
Once acceptable regrowth of scalp hair is achieved, treatment will be maintained as such for more than 3 months and gradually tapered to once every two weeks and will be discontinued over a period of 9 months.
In case if there is no response in 6 months, DPCP will be discontinued .
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of severe alopecia areata (involving loss of >40% scalp hair ) , alopecia totalis and univeraslis attending the Out Patient, Department of Dermatology in Medical College, Kozhikode . |
|
| ExclusionCriteria |
| Details |
Patients who have not given the consent to be a part of the study, pregnant females, patients with less severe variants of alopecia areata and those with serious medical illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic response will be assessed as no response ,minimal response , moderate response,complete response. |
6 months,1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Presence of pruritus, erythema, erosions ,lymph node enlargement ,pigmentary changes like hyperpigmentation or depigmentation |
every month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| 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="2"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Alopecia areata characterised by non scarring hair loss is an autoimmune disease with genetic predisposition triggered by environmental factors.It can be patchy or more severe alopecia totalis involving entire scalp,or alopecia universalis if total body hair is also lost.These severe subtypes often pose a therapeutic challenge and have a devastating impact on quality of life. Topical immunotherapy is the best documented treatment for severe or refractory alopecia areata.We attempt to study the therapeutic response of diphenylcyclopropenone in severe types of alopecia areata due to paucity of similar studies from India. |