Dry SkinNCT06929988
A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry or Sensitive Skin
A study testing Creanz Lotion in people with Dry Skin and Sensitive Skin, run by SAVA Healthcare Limited at 1 site in India.
Trial summary
This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or 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?
- Creanz Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject are generally in good health.
- Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment)
- Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds.
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- 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.
- 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 diseases.
- Subject with present condition of allergic response to any cosmetic product.
- Subject having allergic response to the ink.
- Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment.
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- Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- History of alcohol or drug addiction.
- Subjects using other marketed 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. Contact the study team or a site near you to ask about taking part.
Sheetal J Khandwala contact
India1 site
NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, 382421
Nayan Patel, MBBS, 09909013286, dr.nayan@novobliss.in
Maheshvari N Patel, 09909013286, maheshvari@novobliss.in
About this study
Official title: A Clinical Safety, In-use Tolerability and Efficacy Study of the Test Product in Heathy Adult Human Subjects With Dry or Sensitive Skin
This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or sensitive skin.
Read the detailed description
A total of up to 32 healthy male and non-pregnant | non-lactating female with dry or sensitive skin and an age of 18-55 years will be enrolled to complete the 30 subjects of 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 telephonically by the recruiting department prior to the enrollment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult 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 Visit 02 (Day 02): Evaluations, Product usage period Visit 03 (Day 15 +2 Days): Evaluations, End of the Study
- Conditions
- Dry Skin, Sensitive Skin
- Being tested
- Creanz Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creanz LotionOther
Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin.
Frequency: Twice a Day Route of Administration: Topical
| Study group | Role | What they receive |
|---|---|---|
| Creanz Lotion | Experimental | Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin.
Frequency: Twice a Day Route of Administration: Topical Receives: Other: Creanz Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin hydration
Instrumental Assessment: Corneometer CM 825
Measured: baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin elasticity
Instrumental Assessment: Cutometer Dual MPA 580
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in Dry skin area and severity index
Dermatological assessment: 0 = Absent; 4 = Severe
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in Overall Dry skin Score
Dermatological assessment: 0 = Absent; 4 = Dominated by large scales
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin barrier function
Instrumental Assessment: TEWAMeter TM Hex
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin roughness
Instrumental Assessment: VISIOSCAN VC 20 Plus
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin scaliness
Instrumental Assessment: VISIOSCAN VC 20 Plus
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin smoothness
Instrumental Assessment: VISIOSCAN VC 20 Plus
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in skin wrinkles
Instrumental Assessment: VISIOSCAN VC 20 Plus
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Secondary outcomes (8)
Change in itchiness score
Dermatological Assessment: VAS score 0= no itch,10 = severe itch
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
change in visual assessment of skin dryness,
Dermatological Assessment: 0= absent,4 = Extreme
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin smoothness,
Dermatological Assessment: 0= absent,4 = severe
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin roughness,
Dermatological Assessment: 0= absent,4 = extreme
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin scaliness,
Dermatological Assessment: 0= absent,4 = extreme
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin redness,
Dermatological Assessment: 0= absent,4 = extreme
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin itchiness
Dermatological Assessment: 0= None,4 = severe
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in product perception Questionnaire
Scoring scale: 9-point hedonic scale
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and 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 posted16 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Model description
- Test Product A: Creanz Lotion Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAVA Healthcare Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, MBBS, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929988
- Sponsor's protocol ID
- NB250005-SG
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety, In-use Tolerability and Efficacy Study of the Test Product in Heathy Adult Human Subjects With Dry or Sensitive Skin
- ClinicalTrials.gov ID
- NCT06929988
- Acronym / sponsor ID
- NB250005-SG
- Conditions
- Dry Skin, Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- SAVA Healthcare LimitedUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 Apr 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.
This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or sensitive skin.
Detailed description
A total of up to 32 healthy male and non-pregnant | non-lactating female with dry or sensitive skin and an age of 18-55 years will be enrolled to complete the 30 subjects of 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 telephonically by the recruiting department prior to the enrollment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult 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 Visit 02 (Day 02): Evaluations, Product usage period Visit 03 (Day 15 +2 Days): Evaluations, End of the Study
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Test Product A: Creanz Lotion Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical
| Arm | Type | Receives |
|---|---|---|
| Creanz Lotion | Experimental | Other: Creanz LotionMode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age: 18 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy male and non-pregnant/non-lactating females.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject are generally in good health.
- Subject with dry or sensitive skin at a time of screening. (Dermatological Assessment)
Key exclusion criteria (13 listed)
- History of any dermatological condition of the skin diseases.
- Subject with present condition of allergic response to any cosmetic product.
- Subject having allergic response to the ink.
- Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of 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 |
|---|---|---|
| Creanz LotionMode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical | Other | Creanz Lotion |
Primary outcome
Change in skin hydration
Time frame: baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: Corneometer CM 825
Change in skin elasticity
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: Cutometer Dual MPA 580
Change in Dry skin area and severity index
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Dermatological assessment: 0 = Absent; 4 = Severe
Change in Overall Dry skin Score
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Dermatological assessment: 0 = Absent; 4 = Dominated by large scales
Change in skin barrier function
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: TEWAMeter TM Hex
Change in skin roughness
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
Change in skin scaliness
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
Change in skin smoothness
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
Change in skin wrinkles
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Instrumental Assessment: VISIOSCAN VC 20 Plus
8 secondary outcomes
Change in itchiness score
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
change in visual assessment of skin dryness,
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin smoothness,
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin roughness,
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin scaliness,
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin redness,
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in visual assessment of skin itchiness
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Change in product perception Questionnaire
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Sheetal J Khandwala contact
Nayan Patel, MBBS 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 testing Creanz Lotion in people with Dry Skin and Sensitive Skin, run by SAVA Healthcare Limited 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 12 inclusion and 13 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: opening soon, as of the sponsor's last update on 24 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maheshvari N Patel (09909013286, dr.nayan@novobliss.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin hydration (time frame: baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days)). The study lists 9 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 24 Apr 2025.