None listed
Conditions
Interventions
Intervention1: Marvel AM
Marvel PM: Marvel AM (Lot No. N062117-1, Formula No. 082-17052301.00)
Number of Applications:56 applications ( Day 0 to Day 55)
Route of Administration: Topical application on
Sponsors
SkinMedica Inc AN ALLERGAN COMPANY
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical evaluation by Dermatologist 2. Instrumental evaluation using Corneometer Cutometer Sebumeter Tewameter Chromameter PRIMOSLite Visia CR imaging 3. Histopathological examination immunohistochemistry & biomarker analysis of skin biopsy samples 4. Biochemical analysis of Squalene monohydroperoxyde and malondialdehyde 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
| Measure | Time frame |
|---|---|
| The number of reported Adverse Event/Local intolerance will be used to assess the cutaneous tolerance by the investigatorTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactHaobam Rakesh Singh
CIDP Biotech India Pvt. Ltd
Outcome results
None listed