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Safety and efficacy assessment of Product on skin

Primary objective: To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in acne, reduction in sebum, reduction in pore size and improvement in skin brightening on healthy male and female subjects. Secondary objective: To evaluate the in-vivo efficacy of a skin care formulation in terms of improvement in skin even tone on healthy male and female subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045184
Enrollment
36
Registered
2022-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Acne Mask (EISACM-001): Product to be applied on whole face once in a day in morning and at night product to be applied on only ance for the period of 3 days Control Intervention1: Nil:

Sponsors

SkinQ
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Indian male and female subjects 2 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) 3 Between 18 and 30 years of age. 4 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.) 5 Having mild to moderate acne and oily to mixed oily skin type & visible pores.

Exclusion criteria

Exclusion criteria: 1 For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give his/her assent by not 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 Having acne prone skin. 6 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products. 8 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). 9 Having cutaneous hypersensitivity. 10 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 11 Having changed 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 Refusing to follow the restrictions below during the study: Do not take part in any family planning activities leading to pregnancy and breastfeeding. Do not take part in another study liable to interfere with this study, Do not take 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). Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. During the study: Do not use other cosmetic products than the tested products to the studied areas. Do not use hair oil. The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted). For Males: Shaving should be done before one day of T0 visit and 3 hrs before the night application on T+2 days 14 In the 6 previous months -Having started, changed or stopped a hormonal treatment (hormonal contraception, cyproterone acetate â?¦) - Having taken an oral retinoid-based treatment -Having allergy to asprin / sulpha (salicylic acid). 15 In the previous month - Having undergone a physical (phototherapy, laser ..) or chemical (peeling) treatment for acne -Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment - Having had an oral treatment with a base of cimetidine, zinc (gluconate of zinc) or spironolactone 16 In the 2 previous weeks - Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin - Having had oral or local antibiotic treatment for acne- Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â?¦) -Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 17 Refusing to follow the restrictions below during the study : - Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin - Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â?¦) - Do not start, change or stop a hormonal treatment (hormona

Design outcomes

Primary

MeasureTime frame
reduction in acne, reduction in sebum, reduction in pore size and improvement in skin brighteningTimepoint: baseline, 15 minute, 1 day, 3 days

Secondary

MeasureTime frame
improvement in skin even toneTimepoint: baseline, 15 minute, 1 day, 3 days

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