A clinical study to evaluate the safety, efficacy and in-use tolerability of two different test treatments in healthy adult human subjects.
- Registration Number
- CTRI/2024/01/061138
- Lead Sponsor
- Anveya Living Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Age: 18 to 60 years (both inclusive) at the time of consent.
2)Sex: Healthy non-pregnant/non-lactating females.
3)Subject are generally in good health as determined by/form recent medical history.
4)Subject must have scars (acne scar, hypertrophic scar) on their skin.
5)Subjects with keratosis pilaris/ strawberry legs/ extremely dry skin.
6)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.
7)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.
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 products for scar and bumpy skin other than the test treatments for the entire duration of the study.
10)Willing to use test treatments throughout the study period.
1)Subjects having active infection at site of scars or bumpy skin site.
2)Subject with history of dermatological condition or active dermatological condition.
3)Subject with known allergy or sensitivity to the ingredients of test treatments.
4)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.
5)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6)Subject is currently pregnant/breastfeeding.
7)Subject has a history of any prior scar treatment procedures (e.g., radiofrequency therapy or laser therapy).
8)Subject has a history of alcohol or drug addiction.
9)Subject having any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
10)Subject planning to become pregnant during the study period.
11)Subject with history of chronic illness which may influence the cutaneous state.
12)Subjects participating in other similar trials within the last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)ThriveCo Scar Fader Gel <br/ ><br>1.To assess the effectiveness of the test treatment in terms of visible change in scar. <br/ ><br>2)ThriveCo Bumps Eraser Kit <br/ ><br>1.To assess the effectiveness of the test treatment in terms of change in skin hydration <br/ ><br>2.To assess the effectiveness of test treatment in terms of change in in the skin redness and pigmentation. <br/ ><br>3.To assess the effectiveness of the test treatment in terms of change in skin itchiness.Timepoint: 1)ThriveCo Scar Fader Gel <br/ ><br>From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). <br/ ><br>2)ThriveCo Bumps Eraser Kit <br/ ><br>From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
- Secondary Outcome Measures
Name Time Method