Fine LinesNCT07111156
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.
A study testing Topical Cream containing 0.1% Pinorox® and Topical Cream containing 1% Pinorox® in people with Fine Lines and Wrinkles, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Fine Lines, Wrinkles, Facial Sign of Aging
- What is being tested?
- Topical Cream containing 0.1% Pinorox® and Topical Cream containing 1% Pinorox®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteIndia
- Study dates
- 16 Oct 2025to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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
- Being tested
- Topical Cream containing 0.1% Pinorox®, Topical Cream containing 1% Pinorox®, Placebo (Base Cream)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Topical Cream containing 0.1% Pinorox®; Other: Topical Cream containing 1% Pinorox® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %)
Measured: 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 %)
Measured: 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 %)
Measured: 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 %
Measured: 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
evaluated through PGA scoring using Griffiths scale (minimum score 0- No appearance and maximum score 7-9- severe)
Measured: 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
evaluated through Glogau skin age classification (Type I to Type IV based on wrinkles) Measure changes in %
Measured: 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 %)
Measured: 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 %)
Measured: 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 %)
Measured: 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
Measured: 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)
Measured: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start16 Oct 2025
- Primary completion17 Oct 2025
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111156
- Sponsor's protocol ID
- NB250027-AP_1.0_08Jul25
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07111156
- Acronym / sponsor ID
- NB250027-AP_1.0_08Jul25
- Conditions
- Fine Lines, Wrinkles, Facial Sign of Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Cream containing 0.1% Pinorox® | Experimental | Other: Topical Cream containing 1% Pinorox®, Other: 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. |
| Topical Cream containing 1% Pinorox® | Experimental | Other: Topical Cream containing 0.1% Pinorox®, Other: 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. |
| Placebo (Base Cream) | Placebo comparator | Other: Topical Cream containing 0.1% Pinorox®, Other: 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Placebo (Base Cream), Topical Cream containing 1% Pinorox® |
| 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. | Other | Placebo (Base Cream), Topical Cream containing 0.1% Pinorox® |
| 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. | Other | Topical Cream containing 0.1% Pinorox®, Topical Cream containing 1% Pinorox® |
Primary outcome
Change in skin texture i.e. Crow's feet area wrinkles, fine lines, pores, roughness, dryness, smoothness
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
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 %)
Change in skin elasticity (R2) and firmness (RO)
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
evaluated through Cutometer Dual MPA 580 (R0 and R2) (change in %)
Change in skin pigmentation and dark spots
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
evaluated through Mexameter MX 18 (change in %)
Change in skin colour parameters - L*, a*, b*, and ITA
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
evaluated through Skin Colorimeter CL 400, L*, a*, b*, and ITA measure in change in %
7 secondary outcomes
Change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness
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
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
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
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
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
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
Time frame: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 and Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Cream containing 0.1% Pinorox® and Topical Cream containing 1% Pinorox® in people with Fine Lines and Wrinkles, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin texture i.e. Crow's feet area wrinkles, fine lines, pores, roughness, dryness, smoothness (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.