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

NCT06687512 | Not Yet Recruiting

• 1 other identifier: NB240037-BM
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• 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)

  baseline before usage on Day 01 and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)

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

  Scoring scale indicates 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity

  before usage of the test products on Day 01 and after usage of test products at T30 mins on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

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

  Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3).

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

• 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)

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

Secondary Outcomes (12)

• To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin scaliness

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

• To evaluate the effectiveness of the test products in terms of changes in visual and tactile

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

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

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

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

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

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

  before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).

Study Arms (2)

SaaTwae Bio-Natural Moisturizing Cream

EXPERIMENTAL

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

Other: SaaTwae Bio-Natural Moisturizing Cream

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SaaTwae Bio-Natural Moisturizing Cream OTHER

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

SaaTwae Bio-Natural Moisturizing Cream

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
• \) Subject's with TEWL \>15% 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.
• \) Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that are accessible for instrumental measurements.
• \) Females of childbearing potential should have a negative urine pregnancy test at the time of screening visit.
• \) Subjects (adults and children) are generally in good general health as determined from a recent medical history, except for the atopic dermatitis.
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• \) Subjects and Legal parent or guardian must avoid allowing subject to swim or play in chlorinated water during study period.
• \) Subjects are not allowed to participate in any other study until this study is complete.
• \) 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.
• \) 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.

You may not qualify if:

• )Subjects with AD on the scalp (with hair), palms, and soles. 2) Subjects with active skin infections. 3) 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. 6) 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.
• \) 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.
• \) Pregnant or breastfeeding or planning to become pregnant during the study period.
• \) History of chronic illness which may influence the cutaneous state.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Blossom Microbiotics LLC: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal J Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind Study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: November 13, 2024
• Study Start: November 20, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share