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Safety and Efficacy assessment of Product on skin

To evaluate the comedogenic effect of skincare formulation Cebhydra Lotion on healthy human female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042257
Enrollment
36
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

None listed

Interventions

Intervention1: Cebhydra Lotion: Product will be applied on the whole face, once in a day for a period of 28 days. Control Intervention1: NIL: Not applicable

Sponsors

Sun Pharmaceutical Industries Limited
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 35 years of age. 4)Skin is healthy on the studied anatomic unit (e.g. free of eczema, wounds, inflammatory scar) 5)Having oily or mixed oily skin type on the face. (Visual assessment by dermatologist)

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 assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)In the previous 6 months -Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate) -Having taken an oral retinoid-based treatment -Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne 5)In the previous 1 month -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 (zinc gluconate) or spironolactone 6)In the previous 2 weeks -Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin -Having had oral or local antibiotic treatment for acne 7)In the previous 1 week -Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) -Having a suntanned skin on the studied areas which could interfere with the evaluations of the study

Design outcomes

Primary

MeasureTime frame
comedogenic effectTimepoint: Baseline, 14days, 28days

Secondary

MeasureTime frame
reduction in sebum value , Product SafetyTimepoint: Baseline, 14days, 28days

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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