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Efficacy check of cosmetic product

To evaluate & compare in vivo safety and efficacy of a skin care formulations in terms of reduction in acne (live/occurring), reduction in acne PIH & sebum content on healthy female subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068848
Enrollment
45
Registered
2024-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

None listed

Interventions

Intervention1: ACG 1: Approximately 0.5- 1 gm of test product is applied on whole face. frequency of application is twice in a day for the period of 28days. Intervention2: ACG 2: Approximately 0.5- 1

Sponsors

AVT Natural Products Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 3)Having mild to moderate acne 4)Facial skin and sebum level of forehead more than 100 µg/cm2 5)Having acne PIH dark spots

Exclusion criteria

Exclusion criteria: 1)Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2)Having refused to give her/his assent by signing the consent form. 3)Taking part in another study liable to interfere with this study. 4)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months). 5)Being asthmatic. 6)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex. 7)Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 8)Having cutaneous hypersensitivity. 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.10)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 11)Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 12)Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted). 13)Subjects receiving steroids or antihistamine medications or receiving isotretinoin for treating other conditions.

Design outcomes

Primary

MeasureTime frame
Safety, reduction in acne (live/occurring), reduction in acne PIH & sebum content on healthy female subjectsTimepoint: Baseline, 14 days, 28 days

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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