Healthy ParticipantsNCT07060976
To Check Dermatological Safety of Test Products by 24 Hours Patch Testing
A study of Healthy Participants, run by Novamed Laboratories Pvt. Ltd. at 1 site in India.
Trial summary
To Check Dermatological Safety of Test Products by 24 Hours Patch Testing Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jul 2025to 29 Jul 2025
- 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 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 V (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.
- Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- 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
1 site in 1 country.
About this study
Official title: Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects
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.
- Conditions
- Healthy Participants
- Being tested
- 18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch,Other
Dose: 1×1 cm of each Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1)post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 18 Transdermal patches along with positive and negative controls
1. Capsaicin0.025% Topical Patch,
2. Diclofenac Diethylamine 100mg Transdermal Patch,
3. Diclofenac Diethylamine 200mg Transdermal Patch,
4. Diclofenac Sodium 140 mg Gel Patch,
5. Ketoprofen20 mgTransdermalPatch,
6. Ketoprofen30 mg Transdermal Patch,
7. Lidocaine\& Menthol Topical Patch,
8. Lidocaine350 mg Topical Patch,
9. Lidocaine 4% Topical Patch,
10. Menthol 1.25% Camphor3% Capsaicin 0.025% Topical Patch,
11. Menthol 1.25% Capsaicin0.025% Topical Patch,
12. Menthol10% Topical Patch,
13. Menthol5% Hydrogel Patch,
14. Menthol 5% Topical Patch,
15. Menthol6.0% Camphor3.1% MethylSalicylate 10%,
16. Menthol 6.5% Topical Patch,
17. Menthol7% Camphor 7%Topical Patch,
18. Menthol7.5% 1×1 cm of each Patch (1 cm2) will be applied on subject's back along with 1% SLS (Positive control) and 0.9% Normal saline (Negative Control) Receives: Other: 18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch, |
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
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 as per draize scale
Measured: Post patch removal of 30 minutes, 24 hours & 168 hours
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
Measured: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start21 Jul 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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 Transdermal patches on the back, including the test product(s), a negative control (0.9% Saline), and a positive control (1% sodium lauryl sulfate). Reactions will be assessed at specified time intervals using a standardized Draize Scale
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novamed Laboratories Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NovoBliss Research Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060976
- Sponsor's protocol ID
- NB250023-NL
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT07060976
- Acronym / sponsor ID
- NB250023-NL
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novamed Laboratories Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NovoBliss Research Pvt Ltd
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 11 Jul 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.
To Check Dermatological Safety of Test Products by 24 Hours Patch Testing
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.
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 Transdermal patches on the back, including the test product(s), a negative control (0.9% Saline), and a positive control (1% sodium lauryl sulfate). Reactions will be assessed at specified time intervals using a standardized Draize Scale
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: 18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch,18 Transdermal patches along with positive and negative controls 1. Capsaicin0.025% Topical Patch, 2. Diclofenac Diethylamine 100mg Transdermal Patch, 3. Diclofenac Diethylamine 200mg Transdermal Patch, 4. Diclofenac Sodium 140 mg Gel Patch, 5. Ketoprofen20 mgTransdermalPatch, 6. Ketoprofen30 mg Transdermal Patch, 7. Lidocaine\& Menthol Topical Patch, 8. Lidocaine350 mg Topical Patch, 9. Lidocaine 4% Topical Patch, 10. Menthol 1.25% Camphor3% Capsaicin 0.025% Topical Patch, 11. Menthol 1.25% Capsaicin0.025% Topical Patch, 12. Menthol10% Topical Patch, 13. Menthol5% Hydrogel Patch, 14. Menthol 5% Topical Patch, 15. Menthol6.0% Camphor3.1% MethylSalicylate 10%, 16. Menthol 6.5% Topical Patch, 17. Menthol7% Camphor 7%Topical Patch, 18. Menthol7.5% 1×1 cm of each Patch (1 cm2) will be applied on subject's back along with 1% SLS (Positive control) and 0.9% Normal saline (Negative Control) |
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 V (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 (17 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 |
|---|---|---|
| 18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch,Dose: 1×1 cm of each Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1)post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application | Other | Single Arm |
Primary outcome
To evaluate the dermatological safety of the test products
Time frame: Post patch removal of 30 minutes, 24 hours & 168 hours
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 as per draize scale
1 secondary outcome
Safety of the skin
Time frame: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required.
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 17 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. This study is not recruiting at the moment.
Nayan Patel principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Participants, run by Novamed Laboratories 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 13 inclusion and 17 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 17 Sep 2025. 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. 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?
To evaluate the dermatological safety of the test products (time frame: Post patch removal of 30 minutes, 24 hours & 168 hours). 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 17 Sep 2025.