A trial to check the growth of microorganism on skin of subjects with acne as compared non acne subjects

Not Applicable

• Registration Number: CTRI/2024/02/062767
• Lead Sponsor: SCELSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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 post menopausal 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 pro pigmenting (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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin <br/ ><br>using biopsy samples of the back. <br/ ><br>- To identify acne/phylotype-specific transformations in the immune microenvironments using biopsy <br/ ><br>samples of the back from healthy and acneic volunteers. <br/ ><br>- To detect microbial species and phylotypes within the back biopsy from healthy and acneic <br/ ><br>volunteers. <br/ ><br>- To isolate and collect the skin microbes for construction of in vitro skin biofilm models. <br/ ><br>Timepoint: baseline visit

Secondary Outcome Measures

Name	Time	Method
To evaluate other skin clinical parameters: sebum content, skin erythema, itching, dandruff and UV <br/ ><br>fluorescence. <br/ ><br>- To evaluate skin/scalp disorders (itching/dandruff), possible aggravation factors & cosmetic routines <br/ ><br>and see if itching and dandruff can be correlated.Timepoint: Day-3 & Day 0