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CTRI Number  CTRI/2018/02/012109 [Registered on: 23/02/2018] Trial Registered Prospectively
Last Modified On: 02/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to determine the safety of Spironolactone 5% topical cream in Healthy adult male subjects.  
Scientific Title of Study   A Phase I, Multiple dose, Placebo controlled parallel group double blind study to evaluate the safety and tolerability of Spironolactone 5% topical cream in Healthy adult male subject.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BA17108802  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikash kumar Singh 
Designation  Principal Investigator 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited Sigma 1 Corporate,
Opposite Mann Party Plot, Off. S.G Highway, Bodakdev
Ahmadabad
GUJARAT
380 054
India 
Phone    
Fax    
Email  vsingh@cliantha.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amol Aiwale 
Designation  Medical Advisor 
Affiliation  Alkem Laboratories 
Address  Alkem Laboratories Ltd. Peninsula Corporate Park,
Ganpatrao Kadam Marg
Mumbai
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  amol.aiwale@alkem.com  
 
Details of Contact Person
Public Query  
Name  Vinayaka Shahavi 
Designation  Senior Manager - Clinical Research 
Affiliation  Alkem Laboratories Ltd 
Address  Alkem Laboratories Ltd. Peninsula Corporate Park,
Ganpatrao Kadam Marg
Mumbai
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  vinayaka.shahavi@alkem.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Ltd, Alkem House, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel west, Mumbai – 400013 Telephone: 022-39829999 
 
Primary Sponsor  
Name  Alkem Laboratories Ltd 
Address  Alkem Laboratories Ltd, Alkem House, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel west, Mumbai – 400013 Telephone: 022-39829999 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikash kumar Singh  Cliantha Research Limited  Cliantha Research Limited Sigma-1 Corporate Opposite Mann Party Plot, Off. S.G Highway, Bodakdev
Ahmadabad
GUJARAT 		 07966135601

vsingh@cliantha.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MEDLINK ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo cream  1 gm of placebo on ventral aspect of forearm (approx 16 cm2 of the body surface area) 
Intervention  spironolactone 5% cream  dose of 1 gm on ventral aspect of forearm (approx 16 cm2 of the body surface area) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1) BMI: 18.5 to 30.0 kg/m2, both inclusive.
2) Able to give written informed consent to participate in the study.
3) Non-smokers and non-tobacco users (i.e. having no history of smoking and tobacco consumption for at least one year prior to study)
4) All volunteers must be judged by the principal or sub-investigator as normal and healthy during a pre-study safety assessment performed within 14 days of the first dose of cream application which will include:
a) A physical examination with no clinically significant finding.
b) Results within normal limits or clinically non-significant for the laboratory tests.
- Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
- All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation. 
 
ExclusionCriteria 
Details  Volunteers must not be enrolled in the study if they meet any one of the following criteria:
1) History of allergic responses to Spironolactone or other related drugs, or any of its formulation ingredients.
2) Volunteer has tattoo, mark of injury/surgery, any discolouration of skin, any other birth mark on application area of skin, any ongoing skin disease or history of frequent skin disease, damaged skin at application sites or has cracks/hardening/scarring at the application site
3) Volunteer has excessive hair at the application site
4) Presence of open sores, or other skin abnormalities at the application site
5) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG and chest X-ray recording].
6) Use of enzyme-modifying drugs [i.e. strong CYP3A inhibitors such as boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, troleandomycin, voriconazole and strong CYP3A inducers such as carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort etc.] within 30 days prior to the first dose of cream application.
7) History or evidence of drug dependence or of alcoholism.
8) History of difficulty with donating blood or difficulty in accessibility of veins.
9) Volunteers who have received a known Investigational drug within ten elimination half life of the administered drug or within 30 days prior to cream application, whichever is greater.
10) Use of Topical analgesic or antihistaminic cream within 14 days prior to first dose of cream application.
11) Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteer’s participation in this study.
12) Institutionalized volunteer (having no association with Cliantha Research Limited, i.e. Employee).
13) Use of medicine [prescribed and over the counter (OTC) medication including herbal remedies] at any time within 14 days prior to first dose of cream application.
14) Found positive in urine test for drugs of abuse and/or alcohol breath test done before check-in.
15) Consumption of grapefruit or grape fruit products within 7 days prior to the first dose of cream application. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint: To compare safety of Spironolactone 5% topical cream versus placebo

Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placebo 		 daily upto 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placebo  At baseline and at day 15 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   02/04/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A Phase I, Multiple dose, placebo controlled parallel group randomised double blind study to evaluate the safety and tolerability of Spironolactone 5% topical cream in Healthy adult male subject.    Hormonal changes of serum testosterone and serum dihydrotestosterone in healthy adult male subject will also be evaluated. The study will be conducted in 30 subjects (i.e. 15 subjects per treatment arm). The study duration will be approx 16 days from the day of check-in during which subjects shall receive a dose of 1 gm of either the test formulation Spironolactone 5% topical cream or placebo formulation on ventral aspect of forearm (approx 16 cm2 of the body surface area) twice daily at an interval of 12 hours (±05 minutes) for 14 consecutive days (i.e. Day 01 to Day 14) under the supervision of trained study personnel. The site of application will be assessed by Skin Irritation Score additionally vital signs, clinical examination and general well being shall also be assessed.

 
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