Health Condition 1: L579- Skin changes due to chronic exposure to nonionizing radiation, unspecified Health Condition 2: L814- Other melanin hyperpigmentation Health Condition 3: L853- Xerosis cutis Health Condition 4: R208- Other disturbances of skin sensation Health Condition 5: L709- Acne, unspecified
Conditions
Interventions
Intervention1: Neuvachiol(R) (Bakuchiol): Neuvachiol(R) (Bakuchiol) 1 percent cream or oil applied twice daily for 12 weeks
Control Intervention1: Placebo(vehicle only): identical in formulation base
Sponsors
K V Natural Ingredients Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or females aged 25â??55 years 2.Fitzpatrick skin types 1 to 5 3.Mild-to-moderate photoaging as assessed by dermatologist 4.Presence of hyperpigmented spots, mild scaling or stinging, or acne Grade 1-2 5.Willingness to refrain from other topical treatments or cosmetic procedures during the study 6.Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to study ingredients 2.Use of retinoids, hydroquinone, corticosteroids, or strong exfoliants within 4 weeks prior to screening 3.Active dermatological conditions other than acne or photoaging 4.Pregnancy or lactation 5.Participation in another clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from baseline to Week 12 in clinical photoaging score, including assessment of wrinkle depth, skin texture, and elasticity, as evaluated by a qualified dermatologist. 2.Change from baseline to Week 12 in hyperpigmentation, assessed using a validated visual grading scaleTimepoint: week 0, week 4, week 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change from baseline to week 12 in acne lesion counts (inflammatory and non-inflammatory lesions).Timepoint: week 0, week 4, week 8, week 12;2.Change from baseline to Week 12 in skin scaling and stinging scores, assessed by investigator grading and subject self-assessment using a Visual Analog Scale (VASTimepoint: week 0, week 4, week 8, week 12;3.Change from baseline to Week 12 in skin hydration, measured using a CorneometerTimepoint: week 0, week 4, week 8, week 12;4.Change from baseline to Week 12 in skin barrier function, assessed by Transepidermal Water Loss (TEWL).Timepoint: week 0, week 4, week 8, week 12;5.Evaluation of subject-reported tolerability and satisfactionTimepoint: week 4, week 8, week 12;6.Incidence and severity of treatment-emergent adverse events (AEs).Timepoint: week 4, week 8, week 12 | — |
Countries
India
Contacts
Public ContactRajesh Haldorai
Pharexcel Consulting private Limited
Outcome results
None listed