A clinical study to determine the safety of Spironolactone 5% topical cream in Healthy adult male subjects.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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. JohnÃ¢â?¬•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 volunteerÃ¢â?¬•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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: To compare safety of Spironolactone 5% topical cream versus placebo <br/ ><br> <br/ ><br>Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placeboTimepoint: daily upto 14 days

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: To compare serum testosterone & serum dihydrotestesterone level of Spironolactone 5% topical cream with placeboTimepoint: At baseline and at day 15