A clinical study to determine the safety, efficacy and in-use tolerability of test treatments in healthy adult human subjects.
- Registration Number
- CTRI/2023/12/060424
- 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 - 60 above (both inclusive) old at the time of consent.
2)Sex: Healthy males and non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative urine pregnancy test.
4)Subjects are generally in good general health as determined from recent medical history.
5)Subjects with mild to moderate dandruff status as per ASFS at screening.
6)Subject have unwashed and untreated scalp for 5 days.
7)Subject must have hyperpigmentation/post inflammatory hyperpigmentation/ melasma/ acanthosis nigricans.
8)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
9)The subject must be able to understand and provide written informed consent to participate in the study.
1)Subject with known allergy or sensitization to test treatment ingredients.
2)History of dermatological condition of scalp other than dandruff.
3)History of alcohol or drug addiction.
4)Subject using other marketed products for dandruff control and/or dark patch removal/corrector product during the study period.
5)Subject who have plans of shaving scalp hair during the study.
6)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition at the reading site that can interfere with the reading.
7)Medication which may affect skin and scalp response and/or past medical history.
8)Subject has any concurrent skin disease.
9)Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs in the past 30 days.
10)Subjects who undergone any laser therapies and chemical peeling.
11)Subjects who are likely to engage in activities that involve excessive exposure to sunlight.
12)Pregnant or breastfeeding or planning to become pregnant during the study period.
13)An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
14)Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study.
15)Participation in other clinical studies simultaneously.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. ThriveCo Dark Patches Corrector Cream <br/ ><br>1.To evaluate the effectiveness of the test treatment in terms of change in dark spots| patches of the skin. <br/ ><br>2.To evaluate the effectiveness of the test treatment in terms of change in hyperpigmentation score. <br/ ><br>2. ThriveCo Scalp Clear Serum <br/ ><br>1.To evaluate the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score.Timepoint: 1. ThriveCo Dark Patches Corrector Cream- <br/ ><br>From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). <br/ ><br> 2. ThriveCo Scalp Clear Serum- <br/ ><br>From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) <br/ ><br>
- Secondary Outcome Measures
Name Time Method