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A skin whitening efficacy and safety study in adult, human male subjects

A skin whitening efficacy and safety study in adult human male subjects. - Not Applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001880
Enrollment
60
Registered
2011-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Mens skin whitening cream: Gently apply 1 FTU(Finger Tip Unit) of the product to cleansed face and neck twice a day for 4 weeks. The product will be massaged 5 to 6 times with the help

Sponsors

Cadila Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age: 18-45 years; both inclusive 2)Sex: Male 3)Volunteer is in good physical health as determined by the Investigator/Co-investigator. 4)Volunteer is willing and able to follow the study directions, to participate in the study, returning for all specified visits, and to apply the product only to the part of the areas as per instructions. 5)Volunteers, who are willing to avoid sun bathing, swimming, prolong sun exposure or artificial UV rays during the study. 6)Able to communicate effectively with study personnel. 7)Able to understand and provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1)Volunteers with acne, skin infections over face, widespread active dermatitis or dermatitis on test area. 2)Volunteers with allergies to cosmetics, moisturizers, and whitening/bleaching agents. 3)Volunteer who has sunburned, chapped, or irritated skin or open wounds on test sites. 4)Volunteer who are willing to continue any other personal care products containing whitening/bleaching properties during study period. 5)Volunteer who are swimmers. 6)History or presence of Diabetes. 7)History of skin cancer or treatment for any type of cancer within the last 2 years. 8)Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, acne, eczema, atopic dermatitis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. porphyria). 9)A positive test result for HIV antibody. 10)Participation in a study involving the same test area within the last 30 days. 11)Volunteer who has a condition or is taking or has taken a medication which, in the investigatorâ??s judgment, makes the volunteer ineligible or places the volunteer at undue risk.

Design outcomes

Primary

MeasureTime frame
1. Clinical Evaluation using skin fairness score 2. Self Evaluation questionnaire to evaluate the product efficacy and sensorial properties 3. Assessment of skin fairness using Minolta ChromameterTimepoint: 1. Baseline visit 2. Week 1 3. Week 2 4. Week 4

Secondary

MeasureTime frame
Clinical evaluation for tolerance and subject compliance to therapyTimepoint: Week 1, 2, 3 and 4

Countries

India

Contacts

Public ContactDr Simran Sethi
ssethi@baresearchindia.com07966135618

Outcome results

None listed

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