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To determine the safety and effectiveness of the test product in Healthy Human Females subjects.

A Two Arm, Two Test Products, Randomized, Evaluator Blinded, Safety, Efficacy and In-Use Tolerability Study of Hair Removal Cream (HRC) in Healthy Human Females Frequent Users of Hair Removal Cream. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062599
Enrollment
32
Registered
2024-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

Intervention1: Test Product A: Test Product A1: Fem Natural Hair Removal Cream Gold Test Product A2: Fem Naturals Hair Removal Cream Rose Test Product A3: Fem Natural Hair Removal Cream Sandal Test Pr

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 and non-lactating females. 3) Frequent user of hair removal cream. 4) Females who wax or shave minimum 1-2 times a month. 5) Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application & agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc. 6) Subjects are generally in good general health as determined from recent medical history. 7) The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results. 8) The subjects who have not waxed or use hair removal cream in past 1 month and who frequently use hair removal cream. 9) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 10) 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. 2) The subject with very fine hair or very slow growth. 3) The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any on application sites. 4) The subject has skin irritation, blemishes, moles, pigmentation, pimples, marks [e.g. tattoos (within the previous 3 months), scars, sunburn], open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading. 5) Medication which may affect skin response or past medical history. 6) The subject has a history of diabetes. 7) The subject has a history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 8) The subject suffering from any active clinically significant skin diseases which may contraindicate. 9) The subject has a history of any skin diseases including eczema, atopic dermatitis or active cancer. 10) The subject has a history of asthma or COPD (Chronic obstructive pulmonary disease). 11) Topical drugs used at the application site. 12) Subject with Self-reported Immunological disorders such as HIV positive, AIDS or systemic lupus erythematosus. 13) 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. 14) Participation in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
1. To evaluate the effectiveness of the test product on skin colour, and skin tone i.e. L, a, b, ITA Angle by using Skin Colorimeter CL400 and also compare with razor usage arm. 2. To assess the effectiveness of the test product on skin hydration or moisturization by using MoistureMeterEpid also compare with razor usage arm. 3. To assess the effectiveness of the test product on skin smoothness, softness, dryness by using scoring scale also compare with razor usage arm. 4. To assess the effectiveness of the test product on hair growth, double hair from on follicle or ingrown hair by using CASLiteNova also compare with razor usage arm. 5. To assess the effectiveness of the test product on visual evaluation at application sites for signs of redness, irritation, itching, dryness, scaliness, burning sensation also compare with razor usage arm by Dermatologist’s trained evaluator. Timepoint: Before application Day 01 (for baseline) and after product removal Day 01, Day 03, and Day 07.

Secondary

MeasureTime frame
To evaluate the effectiveness of test product in terms of subject’s response index. i.e. consumer perception about product usage for sensorial attributes of the test product using hedonic scale.Timepoint: Before application on Day 01 (baseline) and after product removal on Day 01, Day 03, and Day 07.;To evaluate the effectiveness of test product usage and sensorial parameters evaluated by the dermatologist’s trained evaluator using hedonic scale by using CASLiteNova also compare with razor usage arm.Timepoint: From baseline on before application Day 01 and after product removal Day 01, Day 03, and Day 07.

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