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A clinical study to determine the safety, efficacy and in-use tolerability of test treatments in healthy adult human subjects.

An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scalp Kit (ThriveCo Exfoliating Scalp Scrub and ThriveCo Scalp Vitalizing Serum) and ThriveCo Acne Kit (ThriveCo Acne Cleanser and ThriveCo Acne Serum) in healthy adult human subjects having complaint of scalp dandruff and facial acne. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060289
Enrollment
32
Registered
2023-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ThriveCo Scalp Kit (1. ThriveCo Exfoliating Scalp Scrub 2. ThriveCo Scalp Vitalizing Serum ): 1. ThriveCo Exfoliating Scalp Mode Of Usage: Apply the scrub on dry scalp and massage int

Sponsors

Anveya Living Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age: 18 - 50 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 mild to moderate acne on their skin (IGA score 2 to 3). 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.

Exclusion criteria

Exclusion criteria: 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 acne and dandruff control and/or hair growth products 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 on the face that can interfere with the reading. 7)Be wearing any facial makeup on the day of the study visit. 8)Medication which may affect skin and scalp response and/or past medical history. 9)Subject has any concurrent skin disease. 10)Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs or abradant facial procedures in the past 30 days. 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.

Design outcomes

Primary

MeasureTime frame
1. ThriveCo Scalp Kit 1) To assess the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score. 2) To assess the effectiveness of the test treatment in terms change in hair thickness, hair density and scalp condition. 3) To assess the effectiveness of the test treatment in terms of change in scalp skin hydration 2. ThriveCo Acne Kit 1) To assess the effectiveness of the test treatment in terms of change in inflammatory and non-inflammatory lesion. 2) To assess the effectiveness of the test treatment in terms of change in skin hydration. 3) To assess the effectiveness of the test treatment in terms of change in skin sebum level. 4) To assess the effectiveness of the test treatment in terms of change in facial dark spot i.e. blemishesTimepoint: 1. ThriveCo Scalp Kit From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) 2. ThriveCo Acne Kit from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)

Secondary

MeasureTime frame
1.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp appearance i.e. dryness, itchiness, redness, and scalinessTimepoint: From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15;2.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp photographs using CASLite NovaTimepoint: From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15;3.To assess the effect of the test treatment (Scalp Kit) in terms of treatment perception questionnaire using 9-point hedonic scaleTimepoint: After usage of the test treatment on Day 01, Day day 08 and Day 15;4. To assess the effectiveness of the test treatment (Acne kit) in terms of change in acne severity using IGA scaleTimepoint: From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15.;5.To assess the effectiveness of the test treatment (Acne Kit) in terms of change in facial photographs (left/right/center)Timepoint: From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15;6. To assess the effectiveness of the test treatments (Acne Kit) in terms of treatment perception questionnaire using 9-point hedonic scaleTimepoint: After usage of the test treatment on Day 01, Day day 08 and Day 15

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026