Validation of the Process of Wound Creation and EvaluationNCT06379516
Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy
A study testing Moisturising Cream (5%), Moisturising Cream (10%) and Coconut Oil in people with Validation of the Process of Wound Creation and Evaluation, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects. The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation of the Process of Wound Creation and Evaluation
- What is being tested?
- Moisturising Cream (5%), Moisturising Cream (10%) and Coconut Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- 17 Jan 2024to 16 Feb 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
- The subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female.
- No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
- The subject, if female, has a self-reported negative urine pregnancy test.
- The subject is in a good general health as determined from recent medical history.
- The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits.
- The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
Who cannot join
- The subject is currently pregnant/lactating or is planning to become pregnant during the study period.
- The subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products.
- The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
- The subject suffers from any active clinically significant disease or any condition that according to the investigator's discretion warrants exclusion from the study.
- The subject is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Process Validation of Dermatological Wound Creation Techniques: A Study Evaluating Methodology Standardization for Assessment of Treatment Efficacy in Controlled Skin Damage
The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.
The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters.
- Being tested
- Moisturising Cream (5%), Moisturising Cream (10%), Coconut Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturising Cream (5%)Other
This intervention is a moisturiging cream of concentration 5% for topical application to the respective test sites.
Moisturising Cream (10%)Other
This intervention is a moisturiging cream of concentration 10% for topical application to the respective test sites.
Coconut OilOther
This intervention is a 100% pure coconut oil product (Parachute Pure Coconut Oil) for topical application to the respective test sites.
| Study group | Role | What they receive |
|---|---|---|
| Moisturising Cream A | Active comparator | Not described Receives: Other: Moisturising Cream (5%) |
| Moisturising Cream B | Active comparator | Not described Receives: Other: Moisturising Cream (10%) |
| Test Oil | Placebo comparator | Not described Receives: Other: Coconut Oil |
| Untreated | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans Epidermal Water Loss (TEWL)
Using the Tewameter® TM Hex
Measured: Days -02, -01, 01, 02, 05, 08, 28
Skin hydration
Using the Corneometer® CM 825
Measured: Days -02, -01, 01, 02, 05, 08, 28
Skin surface topography
Assessment of skin smoothness, scaliness, roughness, wrinkles using the Visioscan® VC 20plus.
Measured: Days -02, -01, 01, 02, 05, 08, 28
Secondary outcomes (1)
Dermatological Assessment
Visual dermatological evaluation of the skin using the Draize scale where 0 indicates no reactions and 4 indicates severe reactions
Measured: Days -02, -01, 01, 02, 05, 08, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start17 Jan 2024
- Primary completion26 Jan 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of the Process of Wound Creation and EvaluationStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Proof of science/concept
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maheshvari Patel, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379516
- Sponsor's protocol ID
- NB240004-NB-V
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2024
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Process Validation of Dermatological Wound Creation Techniques: A Study Evaluating Methodology Standardization for Assessment of Treatment Efficacy in Controlled Skin Damage
- ClinicalTrials.gov ID
- NCT06379516
- Acronym / sponsor ID
- NB240004-NB-V
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 23 Apr 2024 (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.
The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.
The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Proof of science/concept
| Arm | Type | Receives |
|---|---|---|
| Moisturising Cream A | Active comparator | Other: Moisturising Cream (5%) |
| Moisturising Cream B | Active comparator | Other: Moisturising Cream (10%) |
| Test Oil | Placebo comparator | Other: Coconut Oil |
| Untreated | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
- The subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female.
- No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
- The subject, if female, has a self-reported negative urine pregnancy test.
- The subject is in a good general health as determined from recent medical history.
Key exclusion criteria (5 listed)
- The subject is currently pregnant/lactating or is planning to become pregnant during the study period.
- The subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products.
- The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
- The subject suffers from any active clinically significant disease or any condition that according to the investigator's discretion warrants exclusion from the study.
- The subject is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
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 |
|---|---|---|
| Moisturising Cream (5%)This intervention is a moisturiging cream of concentration 5% for topical application to the respective test sites. | Other | Moisturising Cream A |
| Moisturising Cream (10%)This intervention is a moisturiging cream of concentration 10% for topical application to the respective test sites. | Other | Moisturising Cream B |
| Coconut OilThis intervention is a 100% pure coconut oil product (Parachute Pure Coconut Oil) for topical application to the respective test sites. | Other | Test Oil |
Primary outcome
Trans Epidermal Water Loss (TEWL)
Time frame: Days -02, -01, 01, 02, 05, 08, 28
Using the Tewameter® TM Hex
Skin hydration
Time frame: Days -02, -01, 01, 02, 05, 08, 28
Using the Corneometer® CM 825
Skin surface topography
Time frame: Days -02, -01, 01, 02, 05, 08, 28
Assessment of skin smoothness, scaliness, roughness, wrinkles using the Visioscan® VC 20plus.
1 secondary outcome
Dermatological Assessment
Time frame: Days -02, -01, 01, 02, 05, 08, 28
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 27 Jun 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturising Cream (5%), Moisturising Cream (10%) and Coconut Oil in people with Validation of the Process of Wound Creation and Evaluation, 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 5 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 27 Jun 2024. 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?
Trans Epidermal Water Loss (TEWL) (time frame: Days -02, -01, 01, 02, 05, 08, 28). The study lists 3 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 27 Jun 2024.