Health Condition 1: L814- Other melanin hyperpigmentation Health Condition 2: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Dhathri Fair Skin Cream: A Herbal (Ayurvedic) skin cream intended to impart skin fairness, reduce black spots and intensity of dark circles under the eyes.
Intervention2: Dhathri Fair S
Sponsors
Dhathri Ayurveda Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male and female subjects aged between 18 and 35 years. 2. Subjects who can read, understand, give written informed consent form and who are willing to comply with the study protocol. 3. Subjects of skin grade III, IV, and V (Fitzpatrick Scale). 4. Subjects with any type of skin like oily, normal and dry. 5. Subjects having at least any one of the following: black spots, dark circles under eyes. (Minimum 5 subjects with black spots and Minimum 5 subjects with dark circles under eyes) 6. Subjects showing negative to sensitivity test. 7. Subject who has not participated in a similar investigation in the past four weeks. 8. Subjects having pigmentation freckles, pigmented demarcation lines, and uneven tone skin will also be included.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating. 2. A known history or present condition of allergic response to any cosmetic products. 3. Subjects with a history of Insomnia or sleeplessness. 4. Subject having skin diseases (e.g. moderate to severe acne vulgaris face, psoriasis, active atopic dermatitis, melasma, which will interfere with the test readings. 5. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. 6. Systemic treatment of the skin that may change the state of the skin, in the previous 30 days. 7. Subjects not willing to discontinue other fairness/whitening/ brightening creams including vitamin A derivatives. 8. Subjects showing allergic reactions to any component of the tested products. 9. Subjects who has a history of intense sun exposure. 10. Chronic illness which may influence the cutaneous state of the skin. 11. Subject participating in any other cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remarkable Improvement in imparting Skin Fairness in comparison from visit 1 & visit 3 through Shade card assessment and Digital Photographs Remarkable Improvement in Skin Fairness from visit 1 to visit 3 through Objective and Subject questionnaire Remarkable Improvement in reduction of Black spots and Dark Circles from visit 1 to visit 3 through Objective and Subject questionnaire Assessing the acute and chronic safety through incidence of adverse eventsTimepoint: Shade Card Assessment: Improvement in the Skin Fairness score by 2 shades from baseline and visit 3. Digital Photographs: Improvement in the Skin Fairness by 20% from baseline and visit 3. Quality of Improvement questionnaire-Skin Fairness- Improvement by 8 scores from the visit 1 to visit 3. Quality of Improvement Questionnaire-Black Spots- Reduction of 4 score from visit 1 to visit 3. Quality of Improvement Questionnaire-Dark Circles- Reduction of 4 score from visit 1 to visit 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Moderate Improvement in imparting Skin Fairness in comparison from visit 1 & visit 3 through Shade card assessment and Digital Photographs Moderate Improvement in Skin Fairness from visit 1 to visit 3 through Objective and Subject questionnaire Moderate Improvement in reduction of Black spots and Dark Circles from visit 1 to visit 3 through Objective and Subject questionnaireTimepoint: Shade Card Assessment: Improvement in the Skin Fairness score by 1 shade from baseline and visit 3. Digital Photographs: Improvement in the Skin Fairness by 10% from baseline and visit 3. Quality of Improvement questionnaire-Skin Fairness- Improvement by 4 scores from the visit 1 to visit 3. Quality of Improvement Questionnaire-Black Spots- Reduction of 2 score from visit 1 to visit 3. Quality of Improvement Questionnaire-Dark Circles- Reduction of 2 score from visit 1 to visit 3. | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Poly Clinic
Outcome results
None listed