A Phase II Study on Efficacy Evaluation of Sun Defense Multipurpose Lotions

Efficacy Evaluation of Sun Defense Multipurpose Lotions

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2011/05/001741

Enrollment

120

Registered

2011-05-16

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: 3 Sun Defense Multipurpose Lotions (Lotion A, Lotion B, Lotion C): Lotion reduces Sun induced skin darkening, age spot visibility, improving skin fairness, clarity, hydration(period of

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in the age group of 18 to 50 years Subjects should have minimum number of mild to moderate fine lines 15 subjects having a main/ deep wrinkle (5 under each product group) At least 15 to 20 Subjects with prominent hyper pigmentary dark spots or age spots other than Melasma or Chloasma or Nevi or Rosacea etc (5 to 7 under each product group) Subjects having Chromameter L reading above 50 on cheeks Subjects having Corneometer reading below 30 on cheeks Subjects with Chromameter L difference of at least 5 units between cheeks and sun protected volar Bicep region Subjects willing to give a written informed consent and abide by the protocol sincerely and regularly visit the site for follow up Subjects showing negative reactions in the skin sensitivity test

Exclusion criteria

Exclusion criteria: ? A known history or present condition of Allergic response to any cosmetic product ? Subject having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings ? Subjects having Melasma/ Chloasma/ Nevi/ Post inflammatory hyperpigmentation marks and other forms of severe photo damage at the site of evaluation (Except Hyper-pigmentary age spots/ small post acne marks) ? Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results ? Pregnant/ nursing females ? Subjects who are involved in physical labor work ? Subjects with tattoos, dense hair, moles, warts on face and volar forearms at the site of evaluation. ? Subjects with known sensitivity to sun, sunscreens/ cosmetics/ fragrances ? Subjects having participated in a similar investigation in the past four weeks

Design outcomes

Primary

Measure	Time frame
a. To study Product performance in reducing sun induced skin darkening, age spot visibility, number, size, intensity and improving skin fairness, instant fairness, clarity, hydration and overall appearance in comparison to Baseline (T0). b. To study Product performance in reducing sun induced skin darkening, age spot visibility, number, size, intensity and improving skin fairness, clarity, hydration and overall appearance in comparison to other test products at each time point (T1-T7). Timepoint: 12 weeks	—

Measure

Time frame

a. To study Product performance in reducing sun induced skin darkening, age spot visibility, number, size, intensity and improving skin fairness, instant fairness, clarity, hydration and overall appearance in comparison to Baseline (T0). b. To study Product performance in reducing sun induced skin darkening, age spot visibility, number, size, intensity and improving skin fairness, clarity, hydration and overall appearance in comparison to other test products at each time point (T1-T7). Timepoint: 12 weeks

—

Secondary

Measure	Time frame
To study Product performance in reducing fine lines and wrinkles and improving skin smoothness, firmness, suppleness/softness, radiance/ glow, young appearance and healthy appearance as compared to Baseline (T0).Timepoint: 12 Weeks	—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

mukta.sachdev@mscr.in91-80-40917253

Outcome results