| CTRI Number |
CTRI/2024/02/062767 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cosmetic study |
| Study Design |
Other |
|
Public Title of Study
|
A trial to check the growth of microorganism on skin of subjects with acne as compared non acne 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 |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Amended 2122CICL028 Version 1.0 dated 02 Jan 2024 |
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 |
Dermatology room
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
Central
DELHI
110005
India |
| Phone |
9582645711 |
| 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 |
Dermatology room
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi-110005, India
DELHI
110005
India |
| Phone |
9582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Arora |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
Evaluation room
32 B, First floor, Pusa Road, Rajinder Nagar, New Delhi-110005, 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 |
SCELSE |
| Address |
60 Nanyang Drive, SBS-01N-27
Singapore 637551 |
| Type of Sponsor |
Research institution |
|
|
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 |
32 B First Floor, Pusa Road, Rajinder Nagar
Central
DELHI |
9582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Half of the subjects (39 subjects) will be selected
with healthy skin condition and half of the
subjects (39 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 |
If any following non-inclusion criterion applies, the subject must not be included in the study:
I. 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 postmenopausal female (with absence of menstruations for more than one year).
4. Subject with BMI greater than 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 ofbums, 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.
I 0. 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.
I I. Having used oral lsotretinoin treatment in adolescence or adult age.
I 2. Having used within the last month before inclusion any depigmenting I whitening or propigmenting (incl. self-tanning) topical treatments or having planned to use these treatments
during the study on the face.
I 3. Having used, within the past 6 months, any physical treatment including laser or
phototherapy (PUV A, IPL, PDT), Botox or fillers like hyaluronic acid on the investigational
sites or having planned to use these treatments during the study.
I 4. Having used any cosmetic routines such as scrub, deep cleansing of the skin, to the face
within past 4 weeks and intended to perfom1 them during the study period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin
using biopsy samples of the back.
- To identify acne/phylotype-specific transformations in the immune microenvironments using biopsy
samples of the back from healthy and acneic volunteers.
- To detect microbial species and phylotypes within the back biopsy from healthy and acneic
volunteers.
- To isolate and collect the skin microbes for construction of in vitro skin biofilm models.
|
baseline visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate other skin clinical parameters: sebum content, skin erythema, itching, dandruff and UV
fluorescence.
- To evaluate skin/scalp disorders (itching/dandruff), possible aggravation factors & cosmetic routines
and see if itching and dandruff can be correlated. |
Day-3 & Day 0 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
23/02/2024 |
| 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="0"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin
using biopsy samples of the back.To identify acne/phylotype-specific transformations in the immune microenvironments using biopsy
samples of the back from healthy and acneic volunteers. To detect microbial species and phylotypes within the back biopsy from healthy and acneic
volunteers. 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 |