| CTRI Number |
CTRI/2017/10/010109 [Registered on: 16/10/2017] Trial Registered Prospectively |
| Last Modified On: |
13/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Treatment result and mode of action of topical drug called Diphencyprone in patchy hair loss called alopecia areata |
|
Scientific Title of Study
|
Therapeutic outcome of Diphencyprone and its correlation with lesional immune cell subtypes and serum cytokine profile in alopecia areata-A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P M Rakhavi |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Department of Dermatology and STD,
JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9629482832 |
| Fax |
|
| Email |
rakhavi@vhara.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmisha Chandrashekar |
| Designation |
Additional Professor and HOD |
| Affiliation |
JIPMER |
| Address |
Department of Dermatology and STD
JIPMER Dhanvantri nagar Gorimedu Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894119058 |
| Fax |
|
| Email |
laxmishac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P M Rakhavi |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Department of Dermatology and STD,
JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9629482832 |
| Fax |
|
| Email |
rakhavi@vhara.com |
|
|
Source of Monetary or Material Support
|
| JIPMER intramural research grant,
Jawaharlal Institute of Postgraduate Medical education and research (JIPMER),
Dhanvantri nagar, Gorimedu, Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER intramural grant |
| Address |
Dhanvantri nagar, Gorimedu, Pondicherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rakhavi P M |
JIPMER, Pondicherry |
Department of dermatology
Room number 85
Pondicherry
PONDICHERRY |
9629482832
rakhavi@vhara.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Alopecia areata, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Extensive alopecia areata(more than 30 percent scalp hair loss) |
|
| ExclusionCriteria |
| Details |
1.Patients who have taken any systemic or topical therapy in the last 1 month
2.Concomitant serious intercurrent illness
3.Liver failure
4.Significant cardiovascular disease
5.Pregnant and lactating women
6.Women of child-bearing potential not using contraception
7.Past or current history of tobacco or alcohol use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the therapeutic outcome of diphencyprone in extensive alopecia areata |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the lesional cell subtypes and serum cytokine profile in patient with alopecia areata
2.To study the clinical correlation of cytokines of T-helper and regulatory T cells and lesional immune cell types on treatment with diphencyprone |
1. At baseline
2. At baseline and 6 months
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/12/2017 |
| 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="0"
Days="0" |
|
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)?
|
|
Brief Summary
|
Extensive alopecia areata and those refractory to conventional modalities are treated using topical immunotherapy like diphencyprone. Few studies have in the past reported varying regrowth rates ranging from 4 to 83%, averaging at 50%. It is essential to delineate the efficacy and safety of this treatment modality in our setting. Diphencyprone use is associated with an elevated number of infiltrating leukocytes in the bulbar and suprabulbar area of the hair follicle, apparently newly recruited leukocytes act against autonomously functioning CD4+ and CD8+cells.Very few studies in the past have been conducted to investigate the immune alterations in the scalp that resulted in hair regrowth. Enhanced T-cell-mediated immunity and breakdown of immune tolerance due to deficiency in Tregs may facilitate the occurrence of alopecia areata. Diphencyprone treatment has been associated with decrease in the raised interferon-gamma levels, increase in mRNA expression of interleukins 2, 8, 10, and tumor necrosis factor-alpha in the lesional skin. The drug probably also has a systemic effect even after local administration, as evidenced by regrowth of hair at sites distant from the site of application. The serum cytokine profile of patients following diphencyprone treatment has not been studied. The research questions are What is the efficacy of diphencyprone in alopecia areata? What is the change in immune cell population at the site of treatment with diphencyprone? What is the change in cytokines of T-helper cells (Th1, Th2 and Th17) and regulatory T cells (Tregs) with diphencyprone treatment in alopecia areata and its clinical correlation? |