| CTRI Number |
CTRI/2022/08/044836 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
The skin biofilm profile through microflora sampling for strain isolation |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to check the growth of microorganism on skin of subjects with acne as compared to skin of healthy subjects |
|
Scientific Title of Study
|
A Mono-center, matched-Control Study to Investigate the Skin Biofilm Profile on Asian Acne Volunteers Compared to Healthy Volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol 2122CICL028 Version 01 dated 09 Jun 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32B, First Floor, Pusa road, Rajinder Nagar, New Delhi -110051, India
Central
DELHI
110005
India |
| Phone |
958265711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32B, First Floor, Pusa road, Rajinder Nagar, New Delhi -110051, India
DELHI
110005
India |
| Phone |
958265711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Arora |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32B, First Floor, Pusa road, Rajinder Nagar, New Delhi -110051, India
Central
DELHI
110005
India |
| Phone |
8178206475 |
| Fax |
|
| Email |
d.arora@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| Singapore Centre for Environmental Life Sciences Engineering (SCELSE) Nanyang Technological University |
|
|
Primary Sponsor
|
| Name |
Singapore Centre for Environmental Life Sciences Engineering |
| Address |
60 Nanyang Drive, SBS-01N-27
Singapore 637551
|
| Type of Sponsor |
Other [University] |
|
|
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 Annie Jain |
CIDP Biotech India Pvt. Ltd |
32B, First Floor, Pusa Road, Rajinder Nagar, New Delhi-110005
Central
DELHI |
9582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee-ACEAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Half of the subjects (6 subjects) will be selected with healthy skin condition and half of the subjects (6 subjects) will be selected who will be having acne on face and upper back |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy non-pregnant female volunteer from 18 to 25 years old.
2.Asian population with skin type II-V per Fitzpatrick classification.
3.Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study and throughout the study.
4.Female of childbearing potential willing to undergo urine pregnancy test.
5.For Acne subjects:
a. Acne grading (IGA:3 moderate) on face and back declaring persistent acne since the adolescence.
b. Subjects showing the facial acne at least 15 inflammatory lesions (papules and pustules) and 25 non-inflammatory lesions (blackheads and whiteheads) on the face, and the same count criteria on the upper back for acne volunteers.
6.For Healthy subject: Healthy volunteer without acne on face or back in her life.
7.Subject informed about the study objectives and procedures, and able to understand them.
8.Subject willing to give written informed consent and willing to comply with the study protocol and schedule.
9.Subject willing to shower only with water 2 days before, and not shower 1 day before and not apply any topical hygiene/personal care products on face and body. On the day of evaluation visit, subject willing not to shower and wash their face and not apply topical hygiene/personal care products on face and body. Subject willing to wear loose fitting soft cotton clothes provided by site.
10.Subject willing to have a small 3 mm skin biopsy collected from the back.
11.Agreeable to take a COVID-19 RT-PCR test less than 48 hours before evaluation visit.
|
|
| ExclusionCriteria |
| Details |
1.Nursing, pregnant, or is planning to be pregnant according to subject self-report during the study.
2.Having a history of skin cancer within the past 5 years.
3.Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
4.Subject with BMI> 30.
5.History of allergies, hypersensitivity or any serious reactions to any cosmetic products, and any serious reaction to local anaesthesia, local antibiotic & antiseptic, history of healing defects (hypertrophy, keloid, etc).
6.Subject with any disease state or dermatological disorders affecting the investigational areas (presence of burns, wounds or irritation, naevi, vitiligo, active/history of psoriasis, moles, active eczema, scars, tattoos, excessive hair etc.) that might impair evaluations or increase the health risk to the subject by participating in the opinion of the Investigator.
7.Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
8.Reporting any UV exposure in the past month or planning UV exposure of the face (sunlight or sunbeds) throughout the study.
9.Dermatological or aesthetic procedures on the face and back (deep skin cleansing, dermabrasion, peeling, light-therapy, laser, etc.) within the last 3 months before the screening visit and intending to receive them during the study period.
10.Having used within the 8 past weeks for more than 3 consecutive days any systemic or topical drugs related to antibiotics, anti-inflammatory drug, corticoids, retinoid (topical) or any anti-acne or anti-seborrheic products or having planned to use these treatments during the study.
11.Having used oral Isotretinoin treatment in adolescence or adult age.
12.Having used within the last month before inclusion any depigmenting / whitening or pro-pigmenting (incl. self-tanning) topical treatments or having planned to use these treatments during the study on the face.
13.Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT), Botox or fillers like hyaluronic acid on the investigational sites or having planned to use these treatments during the study.
14.Having used any cosmetic routines such as scrub, deep cleansing of the skin, to the face within past 4 weeks and intended to perform them during the study period.
15.Having used cosmetics for more than 5 consecutive days within the past 7 days related to alpha hydroxyl-acids, vitamin C, hyaluronic acids, any alcohol-based products like toners, facial astringents etc.) or having planned to use these treatments during the study.
16.Having changed their face skin care products and their cosmetic washing habits for the area to be treated (shower gel, shampoo…) within the past 10 days before the screening visit.
17.Having practice any intensive physical activity, sports practice (> 10 hours a week), hammam, sauna or swimming-pool (nautical sports) within the past week before the screening visit or planned during the study.
18.Following a strictly vegetarian, vegan diet or cure of mineral or vitamin supplements before the beginning of the study or planned during the study.
19.Deprivation of freedom by administrative or legal decision or who are under guardianship.
20.Having participated within the 30 days before screening or currently participating in another clinical study.
21.Unable to be contacted by phone in case of emergency.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin using biopsy samples of the back.
2. To isolate and collect the skin microbes for construction of in vitro skin biofilm models.
3. To profile the skin microbiome diversity of healthy and acne skin (face and back) using whole metagenome sequencing.
|
Day-3 & Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate other skin clinical parameters: sebum content and skin erythema |
Day-3 & Day 0 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2022 |
| Date of Study Completion (India) |
10/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="3" |
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)?
Response - NO
|
Brief Summary
Modification(s)
|
- To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin using biopsy samples of the back. - To isolate and collect the skin microbes for construction of in vitro skin biofilm models. - To profile the skin microbiome diversity of healthy and acne skin (face and back) using whole metagenome sequencing.
|