ClinicalTrials.gg
Not yet recruitingNCT07195851Updated Sep 29, 2025

Dermatological Safety and Skin Compatibility Evaluation of Test Products

An interventional study of 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 in Healthy Subjects, sponsored by NovoBliss Research Pvt Ltd. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

NovoBliss Research Pvt Ltd is the lead sponsor of 47 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-65 years (both inclusive) at the time of consent.
  2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
  3. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
  4. Females of must have a self-reported negative pregnancy test.
  5. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
  6. Subject is in good general health as determined by the Investigator on the basis of medical history.
  7. Subjects is willing to maintain the test patches in designated positions for 24 Hours.
  8. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
  9. Subject must be able to understand and provide written to participate in the study.
  10. Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Medication which may affect skin response and/or past medical history.
  3. Subject having history of diabetes
  4. 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.
  5. Subject suffering from any active skin diseases which may contraindicate.
  6. Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
  7. Participation in any patch test for irritation or sensitization within the last four weeks.
  8. Subject having history of asthma or (Chronic obstructive pulmonary disease).
  9. Use of any:

    i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii. Antihistamine medication or drugs within seven (7) days prior to first patch application. iii. Systemic or topical at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)

  10. Topical drugs used at application site.
  11. Subject with Self-reported Immunological disorders such as positive, AIDS and/or systemic lupus erythematous.
  12. 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.
  13. Subject with known allergy or sensitization to medical adhesives, bandages.
  14. Participation in other patch study simultaneously.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Single Arm includes 4 test products along with positive and negative control

    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

    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

Interventions

  • Other1.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

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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).

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

    Time frame: at baseline, 30 mins and 24 hours post patch removal

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Oct 2025, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2025
First posted
Sep 29, 2025
StartEst.
Sep 2025
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2025
Last update
Sep 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07195851
Lead sponsor
NovoBliss Research Pvt Ltd
Collaborators
OneSto Labs Private Ltd.
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Sep 2025 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Sep 29, 2025

Study contacts

Maheshvari N Patel
Contact
maheshvari@novobliss.in
919909013236
Sheetal Khandwala
Contact
bd@novobliss.in
Dr. Nayan Patel
principal investigator · NovoBliss Research Private Limited

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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