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.

NCT ID: NCT07111156

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2026-02-17

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

Detailed Description

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

Conditions

Fine Lines; Wrinkles; Facial Sign of Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Topical Cream containing 0.1% Pinorox®

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.

Group Type: EXPERIMENTAL

Topical Cream containing 1% Pinorox®

Intervention Type: 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)

Intervention Type: 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 1% Pinorox®

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.

Group Type: EXPERIMENTAL

Topical Cream containing 0.1% Pinorox®

Intervention Type: 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)

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

Topical Cream containing 0.1% Pinorox®

Intervention Type: 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.

Topical Cream containing 1% Pinorox®

Intervention Type: 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.

Interventions

Topical Cream containing 0.1% Pinorox®

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.

Intervention Type: OTHER

Topical Cream containing 1% Pinorox®

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.

Intervention Type: OTHER

Placebo (Base Cream)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1) 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.

3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.

4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.

5) Subjects are not allowed to participate in any other study until this study is complete.

6) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.

7) Subjects must agree to record each use of the test products in the subject's diary card on daily basis.

8) Subjects must agree to record medication use during the study

Exclusion Criteria

• 1) 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.

3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.

4) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.

5) Subjects that are pregnant and/or breastfeeding. 6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.

7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.

8) 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.

9) 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.

10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.

11) Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ambe Phytoextracts Pvt. Ltd

INDUSTRY

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nayan Patel

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

NovoBliss Research Private Limited

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

NB250027-AP_1.0_08Jul25

Identifier Type: -

Identifier Source: org_study_id