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Safety and efficacy assessment of Product on skin

Primary objective: To assess the in-vivo efficacy and safety of a skin care formulation in terms improvement in skin brightness & luminosity on healthy female subjects. Secondary objective: To assess the in-vivo efficacy and safety of a skin care formulation in terms improvement in skin even tone, & reduction in melanin content of pigmentary spots (Acne PIH &/or melasma)on healthy female subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045309
Enrollment
36
Registered
2022-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Glow Brightening Serum: Product A: Product to be applied on whole face once in night for the period of 28 days. Moisture balm to be applied after product application. Control Interventi

Sponsors

SkinQ
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Indian 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 45 years of age. 4 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar�.) 5 Having Fitz Patrick Skin type III-IV. 6 Some subjects having visible melasma and some subjects having dark spot (acne PIH) on face (with at least one dark spot >4mm in diameter)

Exclusion criteria

Exclusion criteria: 1 For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months Having refused to give his/her assent by not signing the consent form Taking part in another study liable to interfere with this study Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) Having acne prone skin. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products. 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). Having cutaneous hypersensitivity. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 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) 2 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 his/her cosmetic habits apart from the p.articular conditions mentioned in the protocol, on the studied anatomic unit. Do not practice water activities (swimming pool, sauna, hammam, balneotherapy) 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) 3 Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months. 4 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months. 5 Having taken a Dehydroepiandrosterone based treatment in the previous 6 months. 6 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid�.) in the 2 weeks preceding the start of the study. 7 Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin�) in the previous 12 months. 8 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp �) in the previous year. 9 Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years. 10 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene�) 11 Having applied products with a depigmenting action (hydroquinone or derivates�) in the 4 weeks preceding the start of the study. 12 Having undergone phy

Design outcomes

Primary

MeasureTime frame
improvement in skin brightness & luminosityTimepoint: Baseline, Day14, Day28

Secondary

MeasureTime frame
improvement in skin even tone, skin smoothness & reduction in melanin content of pigmentary spots (Acne PIH &/or melasma)Timepoint: Baseline, Day14, Day28

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