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A clinical study to determine the skin safety and effect of Hair Removal Cream in Healthy Human Females A Frequent Users of Hair Removal Cream

A Proof-of-Concept, Dermal Safety and Efficacy Study of a Depilatory Cream in Healthy Human Females A Frequent Users of Hair Removal Cream

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044577
Enrollment
22
Registered
2022-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

None listed

Interventions

Intervention1: Hair Removal Cream -: For Day 1 to 7 Step-1 Apply directly onto the skin with a spatula’s wide base and spread the cream evenly to fully cover the hair. Step-2 Wait for 3-6 minutes & th

Sponsors

Visage Lines Personal Care Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age - 18 to 35 years (both inclusive) old at the time of consent. 2) Sex - Healthy human non-pregnant/non-lactating females 3) Frequent user of hair removal cream 4) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 before application, and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc. 5) Subjects are generally in good general health as determined from recent medical history. 6) The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results. 7) The subjects who have not waxed or removed their limbs for more than 10 days and who regularly depilator their limbs using hair removal cream. 8) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 9) 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 such urea, paraffinum liquidum, cetearyl alcohol, acrylates copolymer, potassium thioglycolate, calcium hydroxide, talc, ceteareth-20, glycerin, sorbitol, magnesium trisilicate, propylene glycol, lithium magnesium sodium silicate, sodium gluconate, tocopheryl acetate, Aloe Barbadensis (Aloe Vera) leaf extract, butylphenyl methylpropional, allantoin, bisabolol, Butyrospermum Parkii (Shea Butter), Fragrance or any other ingredients. 2) The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any on application sites. 3) 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. 4) Medication which may affect skin response and/or past medical history. 5) The subject has a history of diabetes. 6) 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. 7) The subject suffering from any active clinically significant skin diseases which may contraindicate. 8) The subject has a history of any skin diseases including eczema, atopic dermatitis or active cancer. 9) The subject has a history of asthma or COPD (Chronic obstructive pulmonary disease). 10) Topical drugs used at the application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus. 12) 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. 13) Participation in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the test product on skin colour, and tone using Skin ColorimeterTimepoint: Baseline Day 01 before application, at 30 mins after product removal on Day 01 and Day 07

Secondary

MeasureTime frame
To assess the effect of the test product in terms of local irritation (erythema, scaling, itching, and burning) fromTimepoint: Baseline Day 01 before application, after product removal on Day 01 and Day 07;To assess the effect of the test product in terms of product perception about moisturising feel, pain, change of skin colour, smoothness post usage, the fragrance of the product, the effectiveness of hair removalTimepoint: on Day 01 and 07 after product usage;To evaluate the effectiveness of the test product in terms of complete removal of hair, pain, dirt and tan removal, smoothness of skin, dryness, roughness, signs of itching, redness, burning, papular response on the skinTimepoint: Baseline Day 01 before application, after product removal on Day 01 and Day 07

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in91-9909013286

Outcome results

None listed

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