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A clinical study to determine the skin safety and effectiveness of Rosewater in Healthy Female subjects

Single-arm, Open- Label, Randomized, Split-Face Clinical Study to Assess Safety, Efficacy, In-Use Tolerability and Moisture-kinetics of Rosewater in Healthy Female Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052845
Enrollment
32
Registered
2023-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

None listed

Interventions

Intervention1: Rosewater: Dab it directly on the face and forearm with a cotton pad until it get absorbed. duration 1 day Control Intervention1: Not Applicable: Not Applicable

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 55 years (both inclusive) old at the time of consent. 2) Sex: Healthy human non-pregnant/non-lactating females. 3) Frequent regular users of rosewater. 4) Females of childbearing potential must have a self-reported negative urine pregnancy test. 5) Subjects are generally in good general health as determined from recent medical history. 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) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 8) The subject must be able to understand and provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Subject with known allergy or sensitization to product ingredients rose oil, aloe vera. 2) The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, Skin cancer or other skin pathology. 3) Subject participation in the study involving the only one application of a personal care product such as lotion or cleansing product to the test area with no invasive procedure within the four weeks prior to enrolment. 4) Medication which may affect skin response and/or past medical history. 5) Topical drugs used at the application site. 6) An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk. 7) Participation in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of the test product in terms of change in 1. Skin hydration/ moisturization 2. Skin pH 3. Deep Skin PenetrationTimepoint: From baseline to T0, T15min, and T8 hours

Secondary

MeasureTime frame
To assess the safety of the test product in terms of change in Visual evaluationTimepoint: From baseline to T0, T2, T4, T6, T8 hours;To evaluate the product effectiveness in terms of subject response indexTimepoint: From baseline to T0, T2, T4, T6, T8 hours

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

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