None listed
Conditions
Interventions
Intervention1: THV-CRST: Mode of Usage:
Apply coin size quantity and massage the THV-CRST on the focus areas.
Frequency: Use it twice daily.
Route of Administration:
Topical application.
Duration:
Sponsors
Anveya Living Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 20 to 60 years (both inclusive) at the time of consent. 2) Sex: Healthy males and non-pregnant/non-lactating females. For the female post-pregnancy (baby delivery within a week), lactating females can be considered to be inclusive. 3) Subject are generally in good health as determined by/form recent medical history. 4) Subject with measurable stretch marks. 5) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 6) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 7) If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study. 8) Subjects are willing to give written informed consent and are willing to follow the study procedure. 9) Subjects who commit not to use medicated/ prescription anti-stretch marks products or any other anti-stretch mark products other than the test products for the entire duration of the study. 10) Willing to use test products throughout the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects with cardiac, hepatic or renal diseases. 2) Subjects having active infection at site of stretch marks. 3) Subject with history of dermatological condition or active dermatological condition. 4) Subject has a history of allergy or sensitivity to the ingredients of test products. 5) Subject having active herpes simplex infection. 6) Subject having keloidal tendency. 7) Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study. 8) Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study. 9) Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period. 10) Subject is currently pregnant/breastfeeding. 11) Subject has a history of prior use of stretchmark treatment within 3 months. 12) Subject has a history of any prior anti-stretch mark procedures (e.g., radiofrequency therapy or laser therapy). 13) Subject has a history of alcohol or drug addiction. 14) Subject having any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion. 15) Subject planning to become pregnant during the study period. 16) Subject with history of chronic illness which may influence the cutaneous state. 17) Subjects participating in other similar trials or skin care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test products in terms of change in stretch marks of test products using VSS score. 2. To assess the effectiveness of the test products in terms of change in width of stretch marks using digital Vernier calliper 3. To assess the effectiveness of the test products in terms of change in length of stretch marks using ruler Timepoint: Day 01, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test products in terms of change in stretch marks by comparing the digital photographs taken from the body part where stretch marks are present Timepoint: Day 01, Day 30, Day 60;2. To assess the effectiveness of the test products in terms of change in area & intensity of stretch marks from digital photographs using Image-Pro SoftwareTimepoint: Day 01, Day 60;3. To assess the consumer perception of the test products using subject perception questionnaire.Timepoint: Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed