| CTRI Number |
CTRI/2009/091/000896 [Registered on: 02/02/2010] |
| Last Modified On: |
05/09/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil + Finasteride Solution in Comparison with Minoxidil Solution in Adult Male Patients with Androgenic Alopecia |
Scientific Title of Study
Modification(s)
|
An Open Label, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil (5%) + Finasteride (0.1%) Lipid Solution in Comparison with Minoxidil (5%) Solution in Adult Male Patients with Androgenic Alopecia |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CT/MIFI FD/III/09 |
DCGI |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajendra C Rane |
| Designation |
Sr Vice President |
| Affiliation |
Intas Pharma |
| Address |
Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad
Intas Pharmaceuticals Chinubhai Centre Ashram Road Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
26576655 |
| Fax |
26576616 |
| Email |
rane@intaspharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Hardik Pathak |
| Designation |
|
| Affiliation |
Intas Pharma |
| Address |
Medical Services Intas Pharmaceuticals Ltd
Chinubhai Center Ashram Road
Ahmadabad
GUJARAT
380009
India |
| Phone |
66117407 |
| Fax |
26576616 |
| Email |
hardik_pathak@intaspharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Hardik Pathak |
| Designation |
|
| Affiliation |
|
| Address |
Medical Services Intas Pharmaceuticals Ltd
Chinubhai Center, Ashram Road
Ahmadabad
GUJARAT
380009
India |
| Phone |
66117407 |
| Fax |
26576616 |
| Email |
hardik_pathak@intaspharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Limited, Ahmedabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd Floor Chinubhai Center Ashram Road Ahmedabad 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Siddhi B. Chikhalkar |
Ankur Hospital |
Vijay Kunj Building, ,Kanjurmarg (E), -
Mumbai
MAHARASHTRA |
022-25662122
|
| Dr. Anurag Tivari |
Centre for Skin Diseases, Skin Surgery, Cosmetology & Laser Treatments |
E4/42, Bittan Market Choraha, ,Behind Aapoorti Super Bazar, Arera Colony, -462016
Bhopal
MADHYA PRADESH |
0755- 4278278
t_anurag@hotmail.com |
| Dr Mrs Meena B Makhecha |
Dr. (Mrs.) Meena B. Makhecha |
1- Urvashi, Behind HSBC Bank, JVPD Scheme, ,Road No.10, Near Sukmani Bus Stop, -400049
Mumbai
MAHARASHTRA |
022-26200926
makhecha@gmail.com |
| Dr. Bharat I. Lalwala |
Dr. Bharat I. Lalwala |
4/747, 2nd Floor, Opp. Maskati Hospital,,Tower Road,-395003
Surat
GUJARAT |
0261-2431102
bilalwala@yahoo.com |
| Dr. Girish H. Shah |
Dr. Girish H. Shah |
108, Takshashila Apartment,,Majuragate,-
|
0261-2475200
0261-2475600
|
| Dr. Janak K. Thakkar |
Dr. Janak K. Thakkar |
101, Manek Commercial Centre, ,Near Lodhawad Police station, S.V.P. Road, -360002
Rajkot
GUJARAT |
0281-2227171
|
| Dr. Amit Shrikant Kelkar |
Dr. Kelkar's Skin Clinic |
Udyog Bhavan A, Tilak Road,,Hirabaug Chowk-411037
Pune
MAHARASHTRA |
020-24448579
kelkaramit@rediffmail.com |
| Dr. Sushil T. Tahaliani |
Dr. Sushil T. Tahaliani |
105, Arun bazaar, S.V. Road, ,Malad(W), -400064
Mumbai
MAHARASHTRA |
022-28885708/32822
|
| Dr. Umesh K. Nihalani |
Dr. Umesh K. Nihalani |
D-1 Block, Shantiniketan Appartment,,Opp. H.B. Kapadia School, Gurukul Road, Memnagar-380052
Ahmadabad
GUJARAT |
079-27495299
umeshnihalani@rediffmail.com |
| Dr. Mansukh Ghalla |
Gala Skin & Hair Clinic |
203, Chanchal Smruti, 450/B, Dr. B. A. Road, ,Near jain Mandir, Maheshwari Udyan, Matunga(E), -400019
Mumbai
MAHARASHTRA |
022-24096224
|
| Dr. Girish K. Shah |
GK Skin and Laser Centre |
4, Arvind Apartment, Opp. T. B. Zaveri,,Behind Woodland, L.T. Road, Borivali (West), -400092
Mumbai
MAHARASHTRA |
022- 28986018/ 28981412
drgkshah54@yahoo.co.in |
| Dr. Pankaj H. Maniar |
Maniar Skin & Hair Clinic |
?Chandra Pushpa? Ground Floor(Back side), Opp. Laxmi Shopping Centre, ,Behind Mayur Furniture, Near Ghatkopar Railway Station, Ghatkopar(W), -400086
Mumbai
MAHARASHTRA |
022-25134560-1
|
| Dr. Sharad Mutalik |
Planet Skin |
95/A/2, Samruddi Apartment, Shivaji Nagar, ,Near PMC Bus Terminus, -411005
Pune
MAHARASHTRA |
020-30524000
sharadmutalik.skindoctor @gmail.com |
| Dr. Jitendra Jhala |
Shraddha Skin care Hospital |
591/12-C, Saraswati Building, ,Near Police Station, -370201
|
9825232077
drjitendrajhala@yahoo.com |
| Dr. Narendra G. Patwardhan |
Shreeyash Hospital |
Opp. Chitale Bandhu Mithaiwale, ,Deccan Gymkhana, -4110004
Pune
MAHARASHTRA |
020-25661020, 25673010
Ngpatwardhan @gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya - Dr. (Mrs.) Meena B. Makhecha |
Approved |
| Independent Ethics Committee - Aditya - Dr. Sushil T. Tahaliani |
Approved |
| Independent Ethics Committee - Aditya - Gala Skin & Hair Clinic |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Ankur Hospital |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Centre for Skin Diseases, Skin Surgery, Cosmetology & Laser Treatments |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Dr. Bharat I. Lalwala |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Dr. Girish H. Shah |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Dr. Janak K. Thakkar |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Dr. Umesh K. Nihalani |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - GK Skin and Laser Centre |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Maniar Skin & Hair Clinic |
Approved |
| Independent Ethics Committee For Research in Human Subjects, Ahmedabad - Shraddha Skin care Hospital |
Approved |
| Mhalasa Independent Ethics Committee, Pune - Dr. Kelkars Skin Clinic |
Approved |
| Mhalasa Independent Ethics Committee, Pune - Planet Skin |
Approved |
| Mhalasa Independent Ethics Committee, Pune - Shreeyash Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Androgenic alopecia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination of Minoxidil (5%) + Finasteride (0.1%) Lipid Solution |
1 ml twice daily for 24 weeks |
| Comparator Agent |
Minoxidil (5%) Solution |
1 ml twice daily for 24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion Criteria:
(1) Male 18 to 45 years of age, with androgenic alopecia with II to V grade on the modified Norwood Hamilton classification
(2) Willingness to maintain the same hair style, approximate length, and hair color throughout the study
(3) Subjects willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
(1) Concomitant dermatological disorders on the scalp
(2) Serious cardiovascular diseases, renal diseases or hepatic diseases
(3) History of drug hypersensitivity, breast disorders or testicular disorders
(4) Wearing a wig or under gone surgical treatment for hair loss
(5) Shaved scalp or undergoing topical scalp treatment
(6) Clinically significant abnormalities on physical examination or laboratory tests
(7) History of medication interfering with the study objectives
(8) Ongoing use of prohibited medications
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in the investigator assessment score for hair growth and scalp coverage |
Each visit from enrollment onwards |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1)Patients assessment of hair growth and loss by hair growth questionnaire.
(2)Change in global photographic assessment for hair growth by 7 point scale.
(3)Any adverse event reported voluntarily, observed or enquired.
(4)Any clinically significant change in the value of laboratory, vital signs and physical examination compared to baseline. |
(1)Each visit from first follow-up onwards.
(2)Baseline, at end of 12 weeks and at the end of study visit.
(3)Each visit from enrollment onwards.
(4)Each visit from enrollment onwards. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="270"
Sample Size from India="270"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
12/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/02/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The proposed trial is intended for comparing the efficacy and safety of fixed dose combination of Minoxidil (5%) + Finasteride (0.1%) lipid solution with Minoxidil (5%) solution in adult male patients with androgenic alopecia. In view of the different mechanisms of action, it is hypothesized that the simultaneous administration of both the molecules should have a synergistic action. The side effects associated with the oral administration would also be reduced. If the dosage of the individual drug could be reduced, it will further improve the safety profile of the therapy. It is also expected that topical administration of finasteride will reduce the systemic exposure of finasteride leading to less adverse effect on the reproductive system i.e. less incidence of loss of libido, erectile dysfunction, ejaculation disorders, breast engorgement or tenderness and effects on testis (pain in testis, hormonal effects etc.). These events are important especially in young and middle aged males as they might demoralize the patient to undergo finasteride treatment for the AGA. The trial will be conducted in Indian patients within India only. First patient enrolment in the study is anticipated in the second week of February, 2010. |