ClinicalTrials.gg
CompletedNCT07109453Updated Aug 7, 2026

To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects

An interventional study of 18 Test Products along with positive and negative control in Normal and Sensitive Skin, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

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

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To Check Dermatological Safety of Test Products by 24 Hours Patch Testing

Read the detailed description

This is single center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion \|Semi occlusion \|Open patch for at least 24 hours (+ 2 hours). Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events. Subject's back i.e. between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.

02

Conditions studied

  • Normal
  • Sensitive Skin
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

  • 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 V (Human skin colour determination scale).
  • Females of 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.
  • 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 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 Skin Condition 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:

  • 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 skin diseases which may contraindicate.
  • Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
  • Participation in any patch test for irritation or sensitization within the last four weeks.
  • Subject having history of asthma or (Chronic obstructive pulmonary disease).
  • Use of any:
  • Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
  • 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)
  • Topical drugs used at application site.
  • Subject with Self-reported Immunological disorders such as 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
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 (actual)

Study arms

  • Experimental
    18 Test Products along with Positive and Negative Control

    1. Deep Hydration Gel 2. Anti-Wrinkle Gel 3. Anti-Aging Gel 4. Under Eye Cream 5. Brightening Cream 6. Moisturizing Cream 7. Anti-Acne Serum 8. Face Toner 9. Anti-Aging Toner 10. Clear Glow Toner 11. Super Anti-Aging Serum 12. Sun Screen SPF50 13. Anti-Pigmentation Serum 14. Super Cleansing Cream 15. Root Revive Hair Serum 16. Root Nourishment Hair Oil 17. Anti-Acne Face Wash 18. Ever Glow Face Wash 0.04 gm/ml of each Test Products along with positive control (1% SLS) and negative controls will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.

    Other: 18 Test Products along with positive and negative control

Interventions

  • Other18 Test Products along with positive and negative control

    1\. Deep Hydration Gel 2. Anti-Wrinkle Gel 3. Anti-Aging Gel 4. Under Eye Cream 5. Brightening Cream 6. Moisturizing Cream 7. Anti-Acne Serum 8. Face Toner 9. Anti-Aging Toner 10. Clear Glow Toner 11. Super Anti-Aging Serum 12. Sun Screen SPF50 13. Anti-Pigmentation Serum 14. Super Cleansing Cream 15. Root Revive Hair Serum 16. Root Nourishment Hair Oil 17. Anti-Acne Face Wash 18. Ever Glow Face Wash 0.04 gm/ml of each Test Products along with positive control (1% SLS) and negative controls will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.

06

What researchers measure

Primary outcomes

  1. To evaluate the dermatological safety of the test products by 24 Hours Patch

    Test Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction

    Time frame: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed

Secondary outcomes

  1. Safety of the skin

    To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction

    Time frame: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required

07

Study locations

1 site
  • NovoBliss Research
    Ahmedabad, Gujarat 382481, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07109453
Lead sponsor
NovoBliss Research Pvt Ltd
Collaborators
Skin Harmony Lifescience Pvt. Ltd
Responsible party
Sponsor
First posted
Aug 7, 2025
Start date
Aug 26, 2025
Primary completion
Sep 3, 2025
Completion
Sep 3, 2025
Last update
Aug 7, 2026

Study contacts

Dr. Nayan Patel
principal investigator · NovoBliss Research Private Limited

Oversight

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

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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