An interventional study of Treatment Cream and Placebo in Atopic Dermatitis, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 44 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →NovoBliss Research Pvt Ltd is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 should have a negative urine pregnancy test at the time of screening visit.
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 /Parental Informed Consent prior to initiate of study procedures.
20) Having childbearing potential, is practicing and agrees to maintain an established method of (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 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Treatment Cream
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
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
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
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.
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)
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
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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)
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
Time frame: before usage and after usage of the test products at 30 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 skin topography
Change in skin topography (a.u.) by VISIOSCAN VC 20
Time frame: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
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.
Time frame: before usage on Day 01 and after usage on Day 30 (±2 Days) and Day 60 (±2 Days)
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
Time frame: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the Safety by trained evaluators and dermatologists.
Safety will be assessed in terms of number of participants with irritation, infection, or worsening of skin condition
Time frame: Safety will be assessed at all time points (30 minutes at Day 01, Day 30, and Day 60)
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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NovoBliss Research Pvt Ltd