Dry SkinNCT06489418

A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry and Sensitive Skin.

A study testing Dew Restore Barrier Repair Cream in people with Dry Skin and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study of Test Product "Dew Restore Barrier Repair Cream" 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?: Dew Restore Barrier Repair Cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteIndia
Study dates: 30 Jul 2024to 29 Aug 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

Age: 18 to 55 years (both inclusive) at the time of consent.
Sex: Healthy male and non-pregnant/non-lactating females (Preferably equal).
Females of childbearing potential must have a self-reported negative pregnancy test.
Subject are generally in good health.
Subject with dry and sensitive skin at a time of screening. (Dermatological Assessment)
Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites

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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.
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.
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.

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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.

India1 site

NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, 382481

Other trials in India

About this study

Official title: A Prospective, Control-arm, Site Randomized, Evaluator-blinded, Single-centre, Safety, and Efficacy Study of Test Product "Dew Restore Barrier Repair Cream" in Healthy Adult Human Subjects With Dry and Sensitive Skin.

Read the detailed description

A total of 27 Subjects will be enrolled to complete 25 Subjects 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 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 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): Product Usage Period, Evaluations
Visit 04 (Day 30 +2 Days): Evaluations, End of Study

Conditions: Dry Skin, Sensitive Skin
Being tested: Dew Restore Barrier Repair Cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dew Restore Barrier Repair CreamOther
Wash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed.
Frequency: Twice a Day Route of Administration: Topical

Study groups in NCT06489418
Study group	Role	What they receive
Dry and Sensitive Skin	Experimental	Wash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel\| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed. Receives: Other: Dew Restore Barrier Repair Cream
Control	No intervention	Wash the application site with warm water and pat dry with towel\| tissue paper.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in DASI Score (Dry Skin/ichthyosis area and severity index). In scoring scale 0 indicates none and 4 indicates extreme.
1. To evaluate the effectiveness of the test product in terms of change in DASI score from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in Dry Skin Score. In scoring scale 0 indicates absent and 4 indicates Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.
1. To evaluate the effectiveness of the test product in terms of change in overall dry skin score (ODS) from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in PGA Score. In scoring scale 0 means No appearance and 7-9 means severe.
1. To evaluate the effectiveness of the test product in terms of change in PGA score from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in Skin Hydration
1. To evaluate the effectiveness of the test product t in terms of change in skin hydration from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in Skin Barrier Function
1. To evaluate the effectiveness of the test product in terms of change in skin barrier function from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in skin roughness
1. To evaluate the effectiveness of the test product in terms of change in skin roughness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in skin scaliness
To evaluate the effectiveness of the test product in terms of change in skin scaliness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in skin smoothness
To evaluate the effectiveness of the test product in terms of change in skin smoothness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Change in skin wrinkles
To evaluate the effectiveness of the test product in terms of change in skin wrinkles from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).

Secondary outcomes (8)

Change in desquamation index
1. To assess the effectiveness of the test product in terms of change in desquamation index from baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin dryness. 0 means absent and 4 means very severe
1. To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in Product Perception Questionnaire. 0 means absent and 4 means very severe
1. To assess the effectiveness of the test product in terms of subject perception questionnaire after usage of the test product from baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin smoothness. 0 means absent and 4 means very severe
To assess the effectiveness of the test product in terms of change in visual assessment of skin smoothness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin roughness. 0 means absent and 4 means very severe
To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin redness. 0 means absent and 4 means very severe
To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin itchiness. 0 means absent and 4 means very severe
To assess the effectiveness of the test product in terms of change in visual assessment of skin itchiness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin scaliness. 0 means absent and 4 means very severe
To assess the effectiveness of the test product in terms of change in visual assessment of skin scaliness from the baseline before and after usage of the test product.
Measured: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202429 Aug 2024

First posted5 Jul 2024
Study start30 Jul 2024
Primary completion29 Aug 2024
Study completion29 Aug 2024

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: A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06489418
Sponsor's protocol ID: NB240032-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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: A Prospective, Control-arm, Site Randomized, Evaluator-blinded, Single-centre, Safety, and Efficacy Study of Test Product "Dew Restore Barrier Repair Cream" in Healthy Adult Human Subjects With Dry and Sensitive Skin.
ClinicalTrials.gov ID: NCT06489418
Acronym / sponsor ID: NB240032-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: 30 Jul 2024 (actual)
Primary completion: 29 Aug 2024 (actual)
Study completion: 29 Aug 2024 (actual)
First posted: 5 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.

Detailed description

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): Product Usage Period, Evaluations
Visit 04 (Day 30 +2 Days): Evaluations, End of Study

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study.

Arm	Type	Receives
Dry and Sensitive Skin	Experimental	Other: Dew Restore Barrier Repair CreamWash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel\| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed.
Control	No intervention	–Wash the application site with warm water and pat dry with towel\| tissue paper.

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 (Preferably equal).
Females of childbearing potential must have a self-reported negative pregnancy test.
Subject are generally in good health.
Subject with dry and sensitive skin at a time of screening. (Dermatological Assessment)

Key exclusion criteria (12 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.
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.

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
Dew Restore Barrier Repair CreamWash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel\| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed. Frequency: Twice a Day Route of Administration: Topical	Other	Dry and Sensitive Skin

Primary outcome

Change in DASI Score (Dry Skin/ichthyosis area and severity index). In scoring scale 0 indicates none and 4 indicates extreme.
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
1. To evaluate the effectiveness of the test product in terms of change in DASI score from the baseline before and after usage of the test product.
Change in Dry Skin Score. In scoring scale 0 indicates absent and 4 indicates Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
2. To evaluate the effectiveness of the test product in terms of change in overall dry skin score (ODS) from the baseline before and after usage of the test product.
Change in PGA Score. In scoring scale 0 means No appearance and 7-9 means severe.
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
3. To evaluate the effectiveness of the test product in terms of change in PGA score from the baseline before and after usage of the test product.
Change in Skin Hydration
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
4. To evaluate the effectiveness of the test product t in terms of change in skin hydration from the baseline before and after usage of the test product.
Change in Skin Barrier Function
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
5. To evaluate the effectiveness of the test product in terms of change in skin barrier function from the baseline before and after usage of the test product.
Change in skin roughness
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
6. To evaluate the effectiveness of the test product in terms of change in skin roughness from the baseline before and after usage of the test product.
Change in skin scaliness
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
To evaluate the effectiveness of the test product in terms of change in skin scaliness from the baseline before and after usage of the test product.
Change in skin smoothness
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
To evaluate the effectiveness of the test product in terms of change in skin smoothness from the baseline before and after usage of the test product.
Change in skin wrinkles
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
To evaluate the effectiveness of the test product in terms of change in skin wrinkles from the baseline before and after usage of the test product.

8 secondary outcomes

Change in desquamation index
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin dryness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in Product Perception Questionnaire. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin smoothness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin roughness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin redness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin itchiness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)
Change in visual assessment of skin scaliness. 0 means absent and 4 means very severe
Time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+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

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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.

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 Dew Restore Barrier Repair Cream 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 12 inclusion and 12 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 DASI Score (Dry Skin/ichthyosis area and severity index). In scoring scale 0 indicates none and 4 indicates extreme. (time frame: on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+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?

On the ClinicalTrials.gov record for NCT06489418.

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.