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A Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of Hyper Pigmentation in adults

A Prospective, Open-labeled, Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of Hyper Pigmentation in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004310
Enrollment
15
Registered
2014-01-15
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: Skin Lightening Soap: Deep wash: Wash the face, neck and arms with the provided soap two times per day morning and in the evening for 90 days Control Intervention1: Nil: Nil

Sponsors

Kumar Organic Products Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Males and females of age group 18-60 years Subjects who are willing to give written informed consent. Subjects with Fitzpatrick Skin types II to IV Subjects with hyper pigmentation disorders such as Melasma and lentigo (mild to moderate). Patient is willing and able to comply with all trial requirements

Exclusion criteria

Exclusion criteria: Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electro-surgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study Past history of allergy to whitening cosmetic products Past history of atopic dermatitis Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day Present history of mental diseases Previous participation in a clinical trial within 6 months. Pregnant or lactating woman Certain medications that may interfere with the study medication (these will be identified by the study Investigator).

Design outcomes

Primary

MeasureTime frame
Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT) Mexameter analysis (Melanin,erythema contents) (Baseline to EOT) Chromameter (L,a and b values) (Baseline to EOT) To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT) Dermatologists assessment (Baseline to EOT) Shade card assessment(Baseline to EOT)Timepoint: Baseline to end of the treatment (Day 90)—

Secondary

MeasureTime frame
Physician global improvement assessment scores. Melasma Quality of life questionnaire before and after the treatment. (Baseline to EOT) To study the performance of the skin lightening soap in imparting the skin whitening by subject self assessment during the visits (Baseline to EOT) - patient satisfaction using grading scale.Timepoint: All Visits—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical research Pvt Ltd

harish@icbiocro.com9900111997

Outcome results

None listed

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