A Clinical Study to Test the Safety and Effectiveness of Pinorox® for Improving Visible Signs of Facial Aging Such as Wrinkles, Fine Lines, and Dark Spots.

NCT07111156 | Active Not Recruiting

• 1 other identifier: NB250027-AP_1.0_08Jul25
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fine Lines; Wrinkles; Facial Sign of Aging

Outcome Measures

Primary Outcomes (4)

• 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 %)

  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 %)

  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 %)

  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 %

  baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60

Secondary Outcomes (7)

• Change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness

  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

  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

  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

  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

  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

Study Arms (3)

Topical Cream containing 0.1% Pinorox®

EXPERIMENTAL

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.

Other: Topical Cream containing 1% Pinorox®; Other: Placebo (Base Cream)

Topical Cream containing 1% Pinorox®

EXPERIMENTAL

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.

Other: Topical Cream containing 0.1% Pinorox®; Other: Placebo (Base Cream)

Placebo (Base Cream)

PLACEBO COMPARATOR

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.

Other: Topical Cream containing 0.1% Pinorox®; Other: Topical Cream containing 1% Pinorox®

Interventions

Topical Cream containing 0.1% Pinorox® OTHER

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.

Placebo (Base Cream); Topical Cream containing 1% Pinorox®

Topical Cream containing 1% Pinorox® OTHER

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.

Placebo (Base Cream); Topical Cream containing 0.1% Pinorox®

Placebo (Base Cream) OTHER

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.

Topical Cream containing 0.1% Pinorox®; Topical Cream containing 1% Pinorox®

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age: 35 to 55 years (both inclusive) at the time of consent. 2) Sex: Adult male and female having Crow's feet area wrinkles, fine lines, facial dark spots.
• \) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
• \) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
• \) Subjects are not allowed to participate in any other study until this study is complete.
• \) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
• \) Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
• \) Subjects must agree to record medication use during the study

You may not qualify if:

• \) Subjects who are on steroids for last six months. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
• \) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
• \) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
• \) Subjects that are pregnant and/or breastfeeding. 6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
• \) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
• \) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
• \) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
• \) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Ambe Phytoextracts Pvt. Ltd: collaborator

Study Sites (1)

NovoBliss Research Private Limited

Ahmedabad, Gujarat, India

Location

Study Officials

• Nayan Patel

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 8, 2025
• Study Start: October 16, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)