| CTRI Number |
CTRI/2019/01/017172 [Registered on: 21/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate the efficacy of Nixiyax on mental wellbeing in subjects with acne problems |
|
Scientific Title of Study
|
A randomized, controlled, open label, investigator initiated clinical study to evaluate the effect of Nixiyax along with standard of care treatment in comparison with standard of care alone on mental wellbeing in subjects with acne vulgaris. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish Udare |
| Designation |
Principal Investigator |
| Affiliation |
Sparkle Skin and Aesthetic Center |
| Address |
Shanti Centre, Second Floor, Sector-17, Vashi, Navi Mumbai
Thane
MAHARASHTRA
400703
India |
| Phone |
9820045061 |
| Fax |
|
| Email |
satish.udare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
#9, 1st Floor, Mythri Legacy, Chelekere Main road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
#9, 1st Floor, Mythri Legacy, Chelekere Main road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Curatio Healthcare (I) Pvt. Ltd,25/13, Whites Road, 4th Floor, Mamatha Complex, Royapettah,
Chennai, 600014
Tamil Nadu
|
|
|
Primary Sponsor
|
| Name |
Curatio Healthcare I Pvt Ltd |
| Address |
25/13, Whites Road, 4th Floor, Mamatha Complex, Royapettah,Chennai, 600014
Tamil Nadu
|
| Type of Sponsor |
Other [Marketing and selling of cosmetic and pharma products] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Shivaji Kerure |
Dr. Amit Kerure Skin Clinic |
Department of Dermatology, Sector 9, Juhu Nagar, Vashi, Navi Mumbai, Maharashtra 400703
Thane
MAHARASHTRA |
9619766139
amitkerure@gmail.com |
| Dr Satish Udare |
Sparkle Skin and Aesthetic Center |
Shanti Centre, Department of Dermatology, Second Floor, above Parichay Hotel, Sector-17, Vashi, Navi Mumbai 400703
Thane
MAHARASHTRA |
9820045061
satish.udare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| SSD Ethics Committee |
Approved |
| SSD Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having Acne Vulgaris |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nixiyax |
standard care of treatment plus Nixiyax 150mg orally in the night for 84 days |
| Comparator Agent |
Standard care of treatment for acne vulgaris |
oral standard care of treatment for acne vulgaris once daily at night for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Must have mild to severe acne Vulgaris
2. Must be willing and able to give informed Consent.
3.Female subjects Non Pregnant and Non lactating |
|
| ExclusionCriteria |
| Details |
1 Known conditions that may interfere with the evaluation of acne vulgaris. Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
2 Subjects allergic to herbal products or any component of the study product
3 Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline
4 History of uncontrolled disease or immune deficient disorder
5 Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair
6 Known HIV or Hepatitis B positive or any other immuno-compromised state
7 Female subjects who are pregnant, nursing or planning to become pregnant during study participation
8 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
9 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. changes in stress assessment questionnaire scores
2. Changes in Serum Cortisol Level |
Day 0, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in
1. Acne lesion count
2. IGA acne severity
3. Dermatology Life Quality Index (DLQI) scores |
Day 0. Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/01/2019 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is an open label, randomized, multicentre, parallel group, two arm
investigator-initiated study. Subjects suffering from mild to severe acne and
meeting all inclusion and no exclusion criteria after signing a written
informed consent will be enrolled in the study. After passing the eligibility
criteria, subjects will be randomized into 2 treatment arms (50:50) to receive
either Nixiyax plus standard of care or standard of care alone.
The
subject will arrive at the study site in a fasted state and blood samples will
be collected for laboratory assessment (cortisol level and safety assessment).
Post blood sample collection, acne severity will be assessed by the
Investigators Global Assessment (IGA) scoring and lesion count. Photograph of
the lesion areas on the face will be taken for documentation.
Stress assessment will be performed by administering different questionnaires.The
impact of stress and acne on the quality of life of the subjects will be
assessed with Dermatology Life Quality Index (DLQI) questionnaire.
|