To study the effect of the products on skin against the impact of pollution.

Not Applicable

Completed

• Registration Number: CTRI/2017/08/009383
• Lead Sponsor: SkinMedica Inc AN ALLERGAN COMPANY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1 Healthy female subjects aged 40-60 years old (both inclusive)

2 Occupationally be exposed to an excessively high concentration of air pollution (i.e.

outdoor workers)

3 Minimum grade 2 of crowâ??s feet wrinkles as per Skin aging atlas, volume IV Indian skin

type, by BAZIN & FLAMENT

4 Have at least grade 2 mild for overall skin damage, skin tone evenness, Tactile

Roughness and visible redness

5 Have lived in this high air pollution area for at least the past 2 years OR they must have

been occupationally exposed to this high air pollution for the past 2 years

6 Not be using fairness or antiaging or sunscreen creams/lotions (preferably about 60%

non users to be included)

7 Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other

active skin conditions on the face and forearm

8 Agree not to use any other product/treatment/soap bar on their face and forearm during the study period

9 Agree not to carry out bleaching or any other procedures including facial etc. on face

and forearm during the study period

10 Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring), during

VISIA imaging

11 Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test

and to use acceptable methods of contraception (

The effective contraceptive methods include: sexually active females of childbearing

potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation),

or should use a medically accepted contraceptive regimen: systemic contraceptive (oral,

implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal

device, intrauterine device (IUD), condom with spermicide)

12 Willing to give a written informed consent

13 Ready to follow instructions and study restrictions during the study period

Exclusion Criteria

1 Known hypersensitivity to any of the study products or constituents

2 Any significant skin pathology in the test area

3 Currently taking any medication including food supplements, which the Investigator

believes may influence the interpretation of the data

4 Having chronic illness or had major surgery in the last year

5 Undergoing any treatment of any skin condition on their face/body

6 Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else

7 Females in pregnancy or lactation at the beginning of the study or planned during the

study

8 Participation in any other clinical trial up to 1 month prior to inclusion and during the

study

9 Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids,

vitamins , etc. that, in the investigatorâ??s judgement, could interfere with the study

treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the

study

10 Who have started, stopped or changed their hormonal treatment(s) (including

contraceptive pill) in the previous one month prior to the study

11 Any history of allergy to local anesthetic, keloids, hypertrophic scar, cardiac disorder,

bleeding tendency, vitiligo, herpes, local infection & epilepsy

Note: Upto 5 days of antibiotic use can be allowed during study period if required, based

on investigatorâ??s judgement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical evaluation by Dermatologist <br/ ><br> 2. Instrumental evaluation using Corneometer Cutometer Sebumeter Tewameter Chromameter PRIMOSLite Visia CR imaging <br/ ><br>3. Histopathological examination immunohistochemistry & biomarker analysis of skin biopsy samples <br/ ><br>4. Biochemical analysis of Squalene monohydroperoxyde and malondialdehyde <br/ ><br>5. Subjective evaluation questionnaireTimepoint: All the evaluation will be done on Day 0, Week 4 & Week 8 except for Biopsy sampling which will be done only on Day 0 & Week 8

Secondary Outcome Measures

Name	Time	Method
The number of reported Adverse Event/Local intolerance will be used to assess the <br/ ><br>cutaneous tolerance by the investigatorTimepoint: Throughout the study