CTRI/2023/09/057526
Recruiting
未知
A randomized, double blind, two arm, comparative, parallel, in-use tolerance, safety and efficacy study of anti-stretchmark serum cream. - NI
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Anveya Living Private Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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