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To assess the safety and efficacy of the night cream.

An open label, single arm, interventional clinical study to assess the efficacy and safety of FloraSoul Ayurveda Rejuvenating Night Cream (Kakadu Plum & Shea Butter) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098035
Enrollment
20
Registered
2025-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: L819- Disorder of pigmentation, unspecified

Interventions

None listed

Sponsors

Alliance Formulation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female participants aged 18 to 50 years with skin types III to V. 2. Participants who have not participated in any other clinical trial in the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Participants who have undergone major dermatological treatments (e.g., topical hydroquinone, tretinoin, cryotherapy, electrosurgery, trichloroacetic acid application, laser, or intense pulsed light) within the past 3 months. 2. History of allergy to cosmetic or whitening products. 3. History of atopic dermatitis or other chronic skin conditions. 4. Frequent sun exposure exceeding 4 hours per day. 5. Pregnant or lactating women. 6. Known hypersensitivity to any component of the test formulation. 7. Any medical or dermatological condition that, in the opinion of the investigator, may make the participant unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Investigator Global Assessment (IGA) of photodamage: Baseline & Week 2 IGA of pigmentation: Baseline & Week 2 Periorbital hyperpigmentation (dark circle) severity scale Crow s feet wrinkle grading (Bazin s scale): Baseline & Week 2 Skin quality grading (radiance, smoothness, pore size, clarity, brightness, tone, luminosity) 1 to 10 scale (investigator & participant) Cutometer & Mexameter: Skin brightness/even tone & wrinkle reduction Baseline & Day 14 Global improvement assessment at final visit: Improved / Unchanged / Deteriorated Standardized photographs: Baseline & End of study Investigator efficacy score (0 4: none to excellent) Dermatology Life Quality Index (DLQI): Baseline & End of studyTimepoint: Baseline and day 14—

Secondary

MeasureTime frame
To monitor any adverse events during the study period and assess quality of lifeTimepoint: Baseline and day 14—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

DK Elite Health Care Centre

saheerose@gmail.com09843591097

Outcome results

None listed

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