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EVALUATION OF THE DARK SPOTS LIGHTENING EFFICACY AND TOLERANCE OF TEST PRODUCT IN WOMEN WITH DARK SPOTS

EVALUATION OF THE PIGMENT LIGHTENING EFFICACY AND TOLERANCE OF TEST PRODUCT IN WOMEN WITH HYPERPIGMENTATION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001908
Enrollment
36
Registered
2011-07-20
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: Depigmentation Cream: Take 0.5 g - 0.75 g approx of product and lightly apply on affected areas of face. Massage gently with fingertips in circular motion for 30 ? 60 seconds. Apply tw

Sponsors

AMRA Remedies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary women with well defined hyperpigmented patch of not less than 2 cms on face (epidermal pigmentation). 2. Between 18 and 45 years. 3. Photo type IV and below. 4. Presenting healthy skin on face. 5. Accepting not to use products with the same end benefit or containing sunscreen during the entire study duration. 6. Willing to avoid unusual sun exposure as far as possible for the entire study duration. 7. For whom the Investigator considers that the compliance will be correct. 8. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 9. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion criteria

Exclusion criteria: 1. Pregnant women and lactating women or women planning pregnancy. 2. Skin allergy antecedents or atopic subject. 3. Hypersensitivity to any cosmetic product, raw material. 4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 5. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 6. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).

Design outcomes

Secondary

MeasureTime frame
Dermatological evaluation for skin tolerance aTimepoint: Day 30 and Day 60.

Primary

MeasureTime frame
Clinical evaluation by MASI scale for pigmentation SIAscopy using cosmetrics on pigmented site for melanin content Self Evaluation Questionnaire to get volunteer perception of productTimepoint: at Visit 1 (Day 0), Visit 2 (Day 30)and Visit 3 (Day 60). at Visit 1 (Day 0), Visit 2 (Day 30)and Visit 3 (Day 60). at Visit 2 (Day 30)and Visit 3 (day 60).

Countries

India

Contacts

Public ContactMrsTulip Bhattacharjee

C.L.A.I.M.S. Pvt. Ltd.

rsjdr@rediffmail.com66758851

Outcome results

None listed

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