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Atopic DermatitisNCT06687512

A Clinical Study to Assess the Safety and Effectiveness of Test Products in Mild to Moderate Atopic Dermatitis (AD) Patients.

A study testing Treatment Cream in people with Atopic Dermatitis, 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

This is an exploratory, proof-of-concept, double-blind, placebo-controlled, randomized, comparative, interventional, prospective, safety in-use tolerability and efficacy study of test products in patients with mild to moderate Atopic Dermatitis. Read more about this study

Who is it for?
Ages 6 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Treatment Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteIndia
Study dates
20 Nov 2024to 20 Feb 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 6 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1) Age: For children: 6 years and above (both inclusive) at the time of parental consent/assent and For Adults: 18 to 65 years (both inclusive) at the time of consent.
  • 2) Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
  • 3) Subject's with TEWL >15 g/m²/h and Moisture level <20% at the time of screening.
  • 4) Subject's with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study.
  • 5) Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that are accessible for instrumental measurements.
  • 6) Females of childbearing potential should have a negative urine pregnancy test at the time of screening visit.
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  • 7) Subjects (adults and children) are generally in good general health as determined from a recent medical history, except for the atopic dermatitis.
  • 8) If subjects (adults and children) are using or taking any prescription or over the counter (OTC) medications prescribed by their physicians, they must be taking the medication for at least 4 weeks.
  • 9) Subject's and child's legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skin care products during the study period.
  • 10) Subject's and child's legal parent or guardian must agree to limit the sun exposure to affected areas such as arms, legs covered during prolonged sun exposure.
  • 11) Subject's and child's legal parent or guardian must agree to dress the subjects in loose clothing to allow easy exposure to the entire body during study visits and throughout study duration of 60 days.
  • 12) Subjects and Legal parent or guardian must avoid allowing the subject a hot or cold beverage within one hour of their scheduled visits and for the duration of all clinic visits, warm beverages are allowed.
  • 13) Subjects and Legal parent or guardian must avoid allowing subject to swim or play in chlorinated water during study period.
  • 14) Subjects are not allowed to participate in any other study until this study is complete.
  • 15) Subjects and child's legal parent or guardian must be willing and able to follow the study directions and to return for all specified visits with the subject.
  • 16) Subjects and Child's legal parent or guardian must be willing to stop using all of the subject's normal body lotions for the duration of the study (8 weeks) and to use the provided test daily lotion as directed.
  • 17) Subjects and Child's legal parent or guardian must agree to record each use of the test products in the subject's diary card on daily basis.
  • 18) Subjects and Child's legal parent or guardian must agree to record medication use during the study.
  • 19) Subject's and child's legal parent or guardian must read, sign, and receive a copy of Informed Consent/Parental Informed Consent prior to initiate of study procedures.
  • 20) Having 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.
  • 21) Subjects willing to give written informed consent and are willing to come for regular follow up.
  • 22) Subjects have not participated in a similar investigation in the past three months.
  • 23) Subjects willing to use test product throughout the study period.

Who cannot join

  • Subjects with AD on the scalp (with hair), palms, and soles.
  • Subjects with active skin infections.
  • Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis).
  • Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation.
  • Subjects with milk allergies.
  • Change in current prescriptions (within 4 weeks of screening) or new and/or additional prescriptions for the skin condition (within 4 weeks of screening) or during the study.
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  • The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
  • The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
  • The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
  • Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer.
  • The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data, such as 3 or more dosage or 3 or more days of anti-inflammatories (within 1 week of study enrolment) or anti-histamines and steroids.
  • The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study.
  • 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.

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: An Exploratory, Proof-of-Concept, Double-Blind, Placebo-Controlled, Randomized, Comparative, Interventional, Prospective, Safety In-Use Tolerability and Efficacy Study of Test Products in Patients With Mild to Moderate Atopic Dermatitis (AD).

This is an exploratory, proof-of-concept, double-blind, placebo-controlled, randomized, comparative, interventional, prospective, safety in-use tolerability and efficacy study of test products in patients with mild to moderate Atopic Dermatitis.

Read the detailed description

A total of 44 patients with mild to moderate Atopic Dermatitis for at least 6 months will be enrolled in the study to complete 40 patients having confirmed diagnosis of atopic dermatitis.

Subjects will be called on the telephone by the recruiting department. Subjects will be pre-screened by the screening department of NovoBliss Research.

Following ethics committee approval and written informed consent or assent, eligible participants underwent the protocol-specified screening assessments, including instrumental measurements and standardized photography.

The subjects will be instructed to visit the facility as per the below visits. Visit 01 (Day 01): Screening, Randomization, Baseline Evaluation, Post application evaluation Visit 02 (Day 15 ±2 Days): Test products usage, Telephonic Follow-up Visit 03 (Day 30 ±2 Days): Test products usage, Evaluations. Visit 04 (Day 60 ±2 Days): Final Evaluation, End of Study.

Being tested
Treatment Cream, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • Treatment CreamOther

    Mode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups.

    Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical

  • PlaceboOther

    Mode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups.

    Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical

Study groups in NCT06687512
Study groupRoleWhat they receive
Treatment CreamExperimentalMode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups. Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical
Receives: Other: Treatment Cream
Placebo CreamPlacebo comparatorMode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups. Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical
Receives: Other: Placebo

What is being measured

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

  1. To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI)

    Scale indicates 0-4 categorical scale (0: absent, 1: slight, 2: moderate, 3: severe, 4: extreme). improvement in DASI score will be evaluated.

    Measured: baseline before usage on Day 01 and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

  2. To evaluate the effectiveness of the test products in terms of changes in SCORAD severity scoring,

    Total SCORAD index is 103. Higher scores indicating greater severity. 0-3 description applies only to individual intensity components (0 indicates none, 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity). Improvement in SCORAD score

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 mins on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  3. To evaluate the effectiveness of the test products in terms of changes in Eczema Area and Severity Index

    The total maximum score for the EASI is 72. Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3). 0-3 description applies only to individual signs. Improvement in EASI score will be evalauted.

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  4. To evaluate the effectiveness of the test products in terms of changes in visual assessment of post inflammatory hyperpigmentation.

    Scoring scale indicates a 0-4 categorical scale (0: absent, 1: slight, 2: mild, 3: moderate, 4: maximum). Improvement in PIHASI score.

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

Secondary outcomes (12)
  1. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin scaliness

    Scoring scale indicates 0: absent and 4: extreme. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  2. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment including roughness

    Scoring scale indicates 0: absent and 4: extreme. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  3. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin redness

    Scoring scale indicates 0: absent and 4: extreme. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  4. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin itchiness

    Scoring scale indicates 0: absent and 4: Severe. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  5. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin dryness

    Scoring scale indicates 0: absent and 4: Severe. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  6. To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin smoothness

    Scoring scale indicates 0: absent and 4: Severe. % of participants reported

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  7. To evaluate the effectiveness of the test products in terms of changes in Visual Analogue Scale for Itching

    Scale where 0 indicates No itching and 100 indicates most severe itching imaginable

    Measured: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

  8. To evaluate the effectiveness of the test products in terms of changes in skin hydration

    Change in skin hydration (a.u.) by Corneometer CM 825

    Measured: baseline before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

  9. To evaluate the effectiveness of the test products in terms of changes in skin barrier function

    Change in skin barrier function (g/m²/h) using TEWAMeter TM Hex

    Measured: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

  10. To evaluate the effectiveness of the test products in terms of changes in skin topography

    Change in skin topography (a.u.) by VISIOSCAN VC 20

    Measured: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

  11. To evaluate the effectiveness impact of the test products in the shift of skin microbiome by collecting skin swab

    Change in shift of skin microbiome by collection skin swab.

    Measured: before usage on Day 01 and after usage on Day 30 (±2 Days) and Day 60 (±2 Days)

  12. To evaluate the effectiveness of the test products in terms of changes in product perception questionnaire

    5-point Likert Scale indicates 1: Not at all and 5: to large extent

    Measured: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

Timeline

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

  1. First posted13 Nov 2024
  2. Study start20 Nov 2024
  3. Primary completion20 Feb 2025
  4. Study completion20 Feb 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687512
Sponsor's protocol ID
NB240037-BM
Status last verified
Aug 2026
First submitted
19 Oct 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment Cream in people with Atopic Dermatitis, 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 23 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 10 Aug 2026. 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?

To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI) (time frame: baseline before usage on Day 01 and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)). The study lists 4 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 10 Aug 2026.

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