A Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects with Facial Signs of Aging
This is a randomized, double-Blind, three-arm, prospective, single-centre clinical study to evaluate the safety, efficacy, and tolerability of pinorox® in subjects with facial signs of aging. A total of 81 subjects (27 subjects/treatment) will be enrolled in the study, comprising male and non-pregnant, non-lactating female participants aged 35 to 55 years (inclusive). Subjects must present with visible Crow's feet wrinkles, fine lines, and facial dark spots at baseline. Participants will be equally distributed across three treatment groups with 27 subjects per group. The study is designed to complete with at least 75 evaluable subjects (25 per treatment group), accounting for potential dropouts or withdrawals during the study period. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be contacted telephonically by recruiting department prior the enrolment visit. There will be total of 3 visits during the study. The duration of the study will be 60 Days (8 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits. Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings.Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations Visit 03 (Day 60, Week 08): Evaluations and Treatment Phase end \| End of Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
81
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed. Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
Mode of Usage: Apply a coin sized (approximately 1 g) amount of the test treatment to the face and gently massage it until fully absorbed. Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
NovoBliss Research Private Limited
Ahmedabad, Gujarat, India
Change in skin texture i.e. Crow's feet area wrinkles, fine lines, pores, roughness, dryness, smoothness
evaluated through Visioscan VC 20 Plus, Crow's feet area wrinkles (score 0-3, score 0 indicate no wrinkles, score 3 indicate severe wrinkles), fine lines, pores, roughness, dryness, smoothness (measure in %)
Time frame: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin elasticity (R2) and firmness (RO)
evaluated through Cutometer Dual MPA 580 (R0 and R2) (change in %)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin pigmentation and dark spots
evaluated through Mexameter MX 18 (change in %)
Time frame: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin colour parameters - L*, a*, b*, and ITA
evaluated through Skin Colorimeter CL 400, L\*, a\*, b\*, and ITA measure in change in %
Time frame: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness
evaluated through PGA scoring using Griffiths scale (minimum score 0- No appearance and maximum score 7-9- severe)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin wrinkles and fine lines
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Mode of Usage: Apply a coin sized (approximately 1 g) amount of the test treatment to the face and gently massage it until fully absorbed. Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
evaluated through Glogau skin age classification (Type I to Type IV based on wrinkles) Measure changes in %
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
Change in skin pigmentation
evaluated through Melasma Area and Severity Index (MASI)(Changein %)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60
Change in skin hydration
evaluated through Corneometer (change in %)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60
Change in skin glow
evaluated through skin Glossymeter (Change in %)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60
Change in facial photographs
through digital photography by Nikon Digital Camera D3300 or Similar
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 (±2 Days) and Day 60 (±2 Days),
Change in product perception questionnaire
regarding change in dark spots, skin appearance, skin hydration, skin texture, reduced fine lines and wrinkles evaluated through 5-point Likert Scale (1-minimum score and 5-maximum score)
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 and Day 60