Can a Bio-Natural cream calm Eczema's itch and flare?
NCT ID NCT06687512
First seen Jul 31, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This trial is testing whether a bio-natural moisturizing cream, called SaaTwae, can safely ease symptoms of mild-to-moderate atopic dermatitis (eczema) in children and adults. Participants will apply the cream or a placebo to affected skin twice daily, and researchers will track changes in dryness, scaling, redness, and overall severity. The goal is to see if this natural option can provide relief and improve skin comfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SaaTwae Bio-Natural Moisturizing Cream (topical)
- What this could lead to
- If effective, this natural moisturizer could offer a gentle, non-prescription option to soothe eczema flare-ups and improve skin comfort.
- What could go wrong
- This is an early, small proof-of-concept study, so results may not hold up in larger groups. The cream may only provide modest relief and could cause skin irritation in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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44 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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. Exclusion Criteria: 1. 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). 4. Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation. 5. 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. 7. The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances. 8. 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. 9. 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. 10. Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer. 11. 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. 12. The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study. 13. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. 14. Pregnant or breastfeeding or planning to become pregnant during the study period. 15. History of chronic illness which may influence the cutaneous state.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, 382481, India
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