Skin PigmentationNCT06384092
Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents
A study testing Test Sun Protection Cream and Benchmark Sun Protection Cream in people with Skin Pigmentation, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Pigmentation
- What is being tested?
- Test Sun Protection Cream and Benchmark Sun Protection Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIndia
- Study dates
- 7 Mar 2024to 13 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 06 Healthy adult subjects aged between 18 to 45 years (both inclusive).
- Healthy adult male and non-pregnant|non-lactating females.
- Female of childbearing potential have self-reported negative urine pregnancy test.
- Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.
- Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
- Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.
- No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.
- Subjects willing to follow study direction and willing to give written informed consent for the participation.
Who cannot join
- Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.
- Use of photosensitizing medications that interfere with UV-induced skin responses.
- Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.
- Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.
- Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.
- Subjects with a history of significant sunburns in the past three months, minimizing the potential for confounding effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardization of UV Exposure Methods (Artificial Source vs. Sunlight) in Dermatological Research: A Comprehensive Investigation Into the Efficacy Assessment Methodology for Anti-tanning Agents Through Process Validation
The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.
- Conditions
- Skin Pigmentation
- Being tested
- Test Sun Protection Cream, Benchmark Sun Protection Cream
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Sun Protection CreamOther
Also called Test Treatment A
Apply directly on the designated site till absorbed.
Benchmark Sun Protection CreamOther
Also called Test Treatment B
Apply directly on the designated site till absorbed.
| Study group | Role | What they receive |
|---|---|---|
| Site T1 | Experimental | Test Product A - Test Sun Protection Cream Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site Receives: Other: Test Sun Protection Cream |
| Site T2 | Active comparator | Test Product B - Benchmark (Sun Protection Cream) Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site Receives: Other: Benchmark Sun Protection Cream |
| Site U1-4 | No intervention | Test Product : No test product applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Melanine index using instrumental assessment
Change in melanin index (MI) before and after the exposure as measured using the Changes in melanin index will be measured by using Mexameter® MX 18.
Measured: Days 1, 3 and 7.
Change in erythema index using instrumental assessment
Change in the erythema index (EI) before and after the exposure as measured using the Mexameter® MX 18.
Measured: Days 1, 3 and 7.
Secondary outcomes (1)
Change in skin erythema/dryness/wrinkles and oedema using draize scale
Visual change in skin erythema/dryness/wrinkles and oedema of the skin using the Draize scale. Where 0=No reaction, 4=severe erythema/wrinkle/oedema
Measured: Days 1, 3 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start7 Mar 2024
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentationStudies 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
- 6 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
- NCT06384092
- Sponsor's protocol ID
- NB240005-NB-V
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2024
- Last updated
- 29 Apr 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of UV Exposure Methods (Artificial Source vs. Sunlight) in Dermatological Research: A Comprehensive Investigation Into the Efficacy Assessment Methodology for Anti-tanning Agents Through Process Validation
- ClinicalTrials.gov ID
- NCT06384092
- Acronym / sponsor ID
- NB240005-NB-V
- Conditions
- Skin Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 25 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 rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Proof of science/concept
| Arm | Type | Receives |
|---|---|---|
| Site T1 | Experimental | Other: Test Sun Protection CreamTest Product A - Test Sun Protection Cream Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site |
| Site T2 | Active comparator | Other: Benchmark Sun Protection CreamTest Product B - Benchmark (Sun Protection Cream) Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site |
| Site U1-4 | No intervention | –Test Product : No test product applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 06 Healthy adult subjects aged between 18 to 45 years (both inclusive).
- Healthy adult male and non-pregnant|non-lactating females.
- Female of childbearing potential have self-reported negative urine pregnancy test.
- Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.
- Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
Key exclusion criteria (6 listed)
- Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.
- Use of photosensitizing medications that interfere with UV-induced skin responses.
- Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.
- Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.
- Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.
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 |
|---|---|---|
| Test Sun Protection CreamAlso: Test Treatment AApply directly on the designated site till absorbed. | Other | Site T1 |
| Benchmark Sun Protection CreamAlso: Test Treatment BApply directly on the designated site till absorbed. | Other | Site T2 |
Primary outcome
Changes in Melanine index using instrumental assessment
Time frame: Days 1, 3 and 7.
Change in melanin index (MI) before and after the exposure as measured using the Changes in melanin index will be measured by using Mexameter® MX 18.
Change in erythema index using instrumental assessment
Time frame: Days 1, 3 and 7.
Change in the erythema index (EI) before and after the exposure as measured using the Mexameter® MX 18.
1 secondary outcome
Change in skin erythema/dryness/wrinkles and oedema using draize scale
Time frame: Days 1, 3 and 7.
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 29 Apr 2024.
- 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.
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 Test Sun Protection Cream and Benchmark Sun Protection Cream in people with Skin Pigmentation, 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 8 inclusion and 6 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 29 Apr 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. 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?
Changes in Melanine index using instrumental assessment (time frame: Days 1, 3 and 7.). The study lists 2 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 29 Apr 2024.