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A clinical study to evaluate the safety and effectiveness of the test product in healthy adult human subjects with dry-sensitive skin.

A prospective, site randomized, single-center, evaluator-blinded, Moisturekinetic, clinical safety and efficacy study of the Test Product EQUALSTWO Moisturiser in healthy adult subjects with dry-sensitive skin. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074765
Enrollment
16
Registered
2024-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: EqualsTwo Baby Moisturizing lotion: Mode of usage: Pump out adequate quantity of Moisturiser into your palm. Gently apply all over your body. Recommended to use twice a day for normal s

Sponsors

Zydus Lifesciences Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 to 55 years (both inclusive) at the time of consent.2.Sex Healthy male and non-pregnant/non-lactating females.3.Subject having Dry and Sensitive Skin with equal ratio.4.Females of childbearing potential must have a self-reported negative pregnancy test.5.Subject are generally in good health.6.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.7.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.8.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.9.Subjects are willing to give written informed consent and are willing to come for regular follow up.10.Subjects who commit not to use any other skincare products for the entire duration of the study.11.Subject who have not participated in a similar investigation in the past three months.12.Willing to use test product throughout the study period

Exclusion criteria

Exclusion criteria: 1.History of any dermatological condition of the skin diseases.2.Subject with present condition of allergic response to any cosmetic product.3.Subject having allergic response to the ink.4.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.5.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.6.History of alcohol or drug addiction.7.Subjects using other marketed products during the study period.8.Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.9.Pregnant or breastfeeding or planning to become pregnant during the study period.10.History of chronic illness which may influence the cutaneous state.11.Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of test product in terms of change in skin hydration from baseline before usage of the test product on Day 02 and after a single application of the test product by using Corneometer CM 825. (Right and left Forearm).Timepoint: At T1 (10 mins) on Day 02, T2 [post 12 hours±1 hours of the application], Day 03, T3 (24 hours ±1 hours) and Day 04, T4 (48 hours ±1 hours).

Secondary

MeasureTime frame
1.To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness from baseline before usage of the test product by dermatologist or dermatologist trained evaluators.Timepoint: At T1 (10 mins) on Day 02 [T2; post 12 hours ±1 hours of the application], Day 03 (T3; 24 hours ±1 hours ) and Day 04 (T4; 48 hours ±1 hours );2.To assess the effect of the test product in terms of subjective product perception from baseline before usage of the test product on Day 02 and after usage of the test product by using 9 point hedonic scale.Timepoint: On Day 02, Day 03 (T3 24 hours plus 15mins) and Day 04 (T4 48 hours plus 15mins).

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

maheshvari@novobliss.in9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026