Dry SkinNCT06489600
A Clinical Study to Assess the Safety, In-use Tolerability of Test Product in Healthy Adult Subjects With Dry and Sensitive Skin.
A study testing No Rays, Thanks Mineral sunscreen in people with Dry Skin and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin, Sensitive Skin
- What is being tested?
- No Rays, Thanks Mineral sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIndia
- Study dates
- 19 Dec 2024to 4 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females)
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject are generally in good health.
- Subject with dry and sensitive skins. (As per the dermatological evaluation).
- Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
Show all 11Show fewer
- If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- Subjects are willing to give written informed consent and are willing to come for regular follow up.
- Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
- Subject who have not participated in a similar investigation in the past three months.
- Willing to use test product throughout the study period.
Who cannot join
- History of any dermatological condition of the skin disease.
- Subject with present condition of allergic response to any cosmetic product.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- History of alcohol or drug addiction.
- The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.
- Subjects having skin infections like bacterial, fungal, viral infections.
Show all 15Show fewer
- The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
- Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
- Subjects having hypersensitive skin.
- Subjects using other marketed sun screen products during the study period.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Interventional, Prospective, Safety, In-Use Tolerability Study of Test Product "No Rays, Thanks Mineral Sunscreen" in Healthy Adult Subjects With Dry and Sensitive Skin.
This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin.
Read the detailed description
A total of 27 subjects with preferably equal number of males and non-pregnant /non-lactating females will be enrolled to ensure a total of 25 subjects complete the study.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult male and female subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage, Post usage evaluation at T15 mins.
- Visit 02 (Day 15 ±2 Days): Evaluations, End of Study
- Conditions
- Dry Skin, Sensitive Skin
- Being tested
- No Rays, Thanks Mineral sunscreen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Rays, Thanks Mineral sunscreenOther
Wash your face with standard facewash and apply a pea size amount on the face in the morning.
Dosage form: semi-solid frequency: Once in a day Route of Administration: Topical
| Study group | Role | What they receive |
|---|---|---|
| No Rays, Thanks Mineral sunscreen | Experimental | Wash your face with standard facewash and apply a pea size amount on the face in the morning. Receives: Other: No Rays, Thanks Mineral sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local intolerance assessment for skin irritation using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
To assess the safety of the test product in terms of change in local intolerance assessment for irritation by dermatological assessment
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
Change in local intolerance assessment for skin dryness using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
To assess the safety of the test product in terms of change in local intolerance assessment for dryness by dermatological assessment
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
Change in local intolerance assessment for skin oedema using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
To assess the safety of the test product in terms of change in local intolerance assessment for oedema by dermatological assessment
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
safety of the test product in terms of local intolerance assessment of irritation (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
To evaluate the safety of the test product in terms of local intolerance assessment of irritation by Patient Global Assessment scale.
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
safety of the test product in terms of local intolerance assessment of dryness (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
To evaluate the safety of the test product in terms of local intolerance assessment of dryness by Patient Global Assessment scale.
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
safety of the test product in terms of local intolerance assessment of oedema (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
To evaluate the safety of the test product in terms of local intolerance assessment of oedema by Patient Global Assessment scale.
Measured: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
Secondary outcomes (10)
where will you rank the test product in terms of appearance in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters- appearance through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of spreadibility in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters- spreadibility through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of texture in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-texture through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of fragrance in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-fragrance through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of absorption in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-absorption through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of colour in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-colour, through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of tackiness in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-tackiness, through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of non-sticky/non-oily in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameters-non-sticky/non-oily through the subject product perception assessment.
Measured: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of light weight in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of change in organoleptic parameter light weight through the subject product perception assessment through the subject product perception assessment.
Measured: On Day 01 after usage of test product at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of satisfaction in which 1 indicate very poor and 5 indicate excellent.
To assess the test product in terms of organoleptic parameter in rate in terms of satisfaction.
Measured: On Day 01 after usage of test product at T15 minutes, and on Day 15 (±2 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Dec 2024
- Primary completion4 Jan 2025
- Study completion4 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies 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
- open-label, interventional, prospective, safety in-use tolerability
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Kayura Effects LLP
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489600
- Sponsor's protocol ID
- NB240031-KE
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2024
- Last updated
- 3 Mar 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Interventional, Prospective, Safety, In-Use Tolerability Study of Test Product "No Rays, Thanks Mineral Sunscreen" in Healthy Adult Subjects With Dry and Sensitive Skin.
- ClinicalTrials.gov ID
- NCT06489600
- Acronym / sponsor ID
- NB240031-KE
- Conditions
- Dry Skin, Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Kayura Effects LLP
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 8 Jul 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.
This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin.
Detailed description
A total of 27 subjects with preferably equal number of males and non-pregnant /non-lactating females will be enrolled to ensure a total of 25 subjects complete the study.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult male and female subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage, Post usage evaluation at T15 mins.
- Visit 02 (Day 15 ±2 Days): Evaluations, End of Study
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, interventional, prospective, safety in-use tolerability
| Arm | Type | Receives |
|---|---|---|
| No Rays, Thanks Mineral sunscreen | Experimental | Other: No Rays, Thanks Mineral sunscreenWash your face with standard facewash and apply a pea size amount on the face in the morning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age: 18 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females)
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject are generally in good health.
- Subject with dry and sensitive skins. (As per the dermatological evaluation).
Key exclusion criteria (15 listed)
- History of any dermatological condition of the skin disease.
- Subject with present condition of allergic response to any cosmetic product.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- History of alcohol or drug addiction.
- The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.
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 |
|---|---|---|
| No Rays, Thanks Mineral sunscreenWash your face with standard facewash and apply a pea size amount on the face in the morning. Dosage form: semi-solid frequency: Once in a day Route of Administration: Topical | Other | No Rays, Thanks Mineral sunscreen |
Primary outcome
Change in local intolerance assessment for skin irritation using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To assess the safety of the test product in terms of change in local intolerance assessment for irritation by dermatological assessment
Change in local intolerance assessment for skin dryness using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To assess the safety of the test product in terms of change in local intolerance assessment for dryness by dermatological assessment
Change in local intolerance assessment for skin oedema using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To assess the safety of the test product in terms of change in local intolerance assessment for oedema by dermatological assessment
safety of the test product in terms of local intolerance assessment of irritation (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To evaluate the safety of the test product in terms of local intolerance assessment of irritation by Patient Global Assessment scale.
safety of the test product in terms of local intolerance assessment of dryness (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To evaluate the safety of the test product in terms of local intolerance assessment of dryness by Patient Global Assessment scale.
safety of the test product in terms of local intolerance assessment of oedema (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
Time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
To evaluate the safety of the test product in terms of local intolerance assessment of oedema by Patient Global Assessment scale.
10 secondary outcomes
where will you rank the test product in terms of appearance in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of spreadibility in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of texture in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of fragrance in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of absorption in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of colour in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of tackiness in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of non-sticky/non-oily in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 and after test product usage on Day 01 at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of light weight in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 after usage of test product at T15 minutes, and on Day 15 (±2 Days)
where will you rank the test product in terms of satisfaction in which 1 indicate very poor and 5 indicate excellent.
Time frame: On Day 01 after usage of test product at T15 minutes, and on Day 15 (±2 Days)
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 3 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Dry Skin
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Not yet recruiting
Effect of Autologous Serum-Soaked Paper Patch vs. Traditional Dry Paper Patch on Tympanic Membrane Perforations
Tympanic Membrane Perforation
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
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.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Rays, Thanks Mineral sunscreen in people with Dry Skin and Sensitive Skin, 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 11 inclusion and 15 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 3 Mar 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?
Change in local intolerance assessment for skin irritation using 4-point scoring scale where 0 indicate absent and 3 indicate severe. (time frame: On Day 01 at T15 minutes and on Day 15 (± 2 Days).). The study lists 6 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 3 Mar 2025.