CTRI/2023/09/057526招募中Unknown
A randomized, double blind, two arm, comparative, parallel, in-use tolerance, safety and efficacy study of anti-stretchmark serum cream. - NI
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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