Healthy SubjectsNCT07195851
Dermatological Safety and Skin Compatibility Evaluation of Test Products
A study of Healthy Subjects, run by NovoBliss Research Pvt Ltd.
Trial summary
Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- Subject is in good general health as determined by the Investigator on the basis of medical history.
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- Subjects is willing to maintain the test patches in designated positions for 24 Hours.
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- Subject must be able to understand and provide written informed consent to participate in the study.
- Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
- For Sensitive Specific Skin Study Only:
- Subject scoring greater than 30 for Section 2 - Sensitive v/s Resistant skin in modified Dr Baumann's skin type questionnaire.
- Subject with sensitive skin as confirmed by Lactic Acid stinging test.
Who cannot join
- Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- Medication which may affect skin response and/or past medical history.
- Subject having history of diabetes
- Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- Subject suffering from any active clinically significant skin diseases which may contraindicate.
- Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
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- Participation in any patch test for irritation or sensitization within the last four weeks.
- Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
- Use of any:
- Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
- Topical drugs used at application site.
- Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- Individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
- Subject with known allergy or sensitization to medical adhesives, bandages.
- Participation in other patch study simultaneously.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sheetal Khandwala contact
About this study
Official title: Dermatological Safety and Skin Compatibility Evaluation of Test Product Following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
Read the detailed description
This is single-centre, evaluator blinded study in healthy human subjects. single 48-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 48hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total four visits in this study. Visit 01 (Day01):Screening, Enrolment and Patch Application, Visit 02 (Day 03):Patch Removal \& 30 ± 5 min irritation scoring upon patch removal. Visit 03 (Day 04): 24 (± 2 hour)irritation scoring (Day 04)Visit 05:
At 48±2 hours Irritation Scoring
- Conditions
- Healthy Subjects
- Being tested
- 1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair MaskOther
Dose: 0.1 ml of sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm includes 4 test products along with positive and negative control | Experimental | Below interventions along with 1% SLS (Positive control) and 0.9% Normal saline (Negative Control) will be applied in subject's forearm
1. Bare Anatomy Expert Advanced Hair Growth Serum
2. Bare Anatomy Expert Ultra-Smoothing Shampoo
3. Bare Anatomy Expert Ultra-Smoothing Hair Serum
4. Bare Anatomy Expert Ultra-Smoothing Hair Mask Receives: Other: 1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition.
Dermatological reactions will be evaluated using the 48-hour patch test method under complete occlusion. Assessments will be performed to detect any skin irritation, erythema, or other local reactions at the application site.
Measured: 30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).
Secondary outcomes (1)
Skin Safety Evaluation by assessing Change in Transepidermal Water Loss (TEWL) at the Application Site
Transepidermal Water Loss (TEWL) at the site of product application will be measured using the TEWAMeter TM Hex to assess the impact of the investigational product on skin barrier function
Measured: at baseline, 30 mins and 24 hours post patch removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will receive test products patches on the forearm, including the test product(s), a negative control (0.9% Saline), and a positive control (1% sodium lauryl sulfate).
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- OneSto Labs Private Ltd.
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195851
- Sponsor's protocol ID
- NB250039-OL
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatological Safety and Skin Compatibility Evaluation of Test Product Following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
- ClinicalTrials.gov ID
- NCT07195851
- Acronym / sponsor ID
- NB250039-OL
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- OneSto Labs Private Ltd.
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Sep 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.
Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
Detailed description
This is single-centre, evaluator blinded study in healthy human subjects. single 48-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 48hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total four visits in this study. Visit 01 (Day01):Screening, Enrolment and Patch Application, Visit 02 (Day 03):Patch Removal \& 30 ± 5 min irritation scoring upon patch removal. Visit 03 (Day 04): 24 (± 2 hour)irritation scoring (Day 04)Visit 05:
At 48±2 hours Irritation Scoring
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will receive test products patches on the forearm, including the test product(s), a negative control (0.9% Saline), and a positive control (1% sodium lauryl sulfate).
| Arm | Type | Receives |
|---|---|---|
| Single Arm includes 4 test products along with positive and negative control | Experimental | Other: 1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair MaskBelow interventions along with 1% SLS (Positive control) and 0.9% Normal saline (Negative Control) will be applied in subject's forearm 1. Bare Anatomy Expert Advanced Hair Growth Serum 2. Bare Anatomy Expert Ultra-Smoothing Shampoo 3. Bare Anatomy Expert Ultra-Smoothing Hair Serum 4. Bare Anatomy Expert Ultra-Smoothing Hair Mask |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
Key exclusion criteria (15 listed)
- Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- Medication which may affect skin response and/or past medical history.
- Subject having history of diabetes
- Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- Subject suffering from any active clinically significant skin diseases which may contraindicate.
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 |
|---|---|---|
| 1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair MaskDose: 0.1 ml of sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours. | Other | Single Arm includes 4 test products along with positive and negative control |
Primary outcome
To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition.
Time frame: 30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).
Dermatological reactions will be evaluated using the 48-hour patch test method under complete occlusion. Assessments will be performed to detect any skin irritation, erythema, or other local reactions at the application site.
1 secondary outcome
Skin Safety Evaluation by assessing Change in Transepidermal Water Loss (TEWL) at the Application Site
Time frame: at baseline, 30 mins and 24 hours post patch removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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.
Sheetal Khandwala contact
Dr. Nayan Patel principal investigator
NovoBliss Research Private Limited
Questions about this trial
What is this clinical trial studying?
A study of Healthy Subjects, run by NovoBliss Research Pvt Ltd.
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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maheshvari N Patel (919909013236, maheshvari@novobliss.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition. (time frame: 30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).). 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 29 Sep 2025.