To assess the efficacy and safety of Orah Glo E for bright and radiant skin.

A randomized, open label, interventional clinical study to assess the efficacy and safety of Orah Glo E for bright and radiant skin. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075429

Enrollment

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: L810- Postinflammatory hyperpigmentation

Interventions

Intervention1: ORAH GLO E: Ingredients: 1. Vitamin E -Tocotrienol Rich Fraction 2. Medium Chain Triglycerides 3. GML 4. Ascorbyl Palmitate Dosage: 0.5 - 3% Usage instructions: Twice a day- Sufficien

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female subjects who are 18 to 45 years of age. (skin types IV to V) 2.Patients with Melasma, Post acne pigmentation, post inflammatory hypermelanosis, Seborrhoeic melanosis, Photo tanning and Frictional melanosis will be included. 3.Subjects not have participated in any other clinical trial during the past 3 months

Exclusion criteria

Exclusion criteria: 1.Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electrosurgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study 2.Past history of allergy to whitening cosmetic products 3.Past history of atopic dermatitis 4.Habit of frequent sun exposure longer than 4 hours per day 5.Pregnant or lactating women. 6.Hypersensitivity to any of the components of the test formulation. 7.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

Design outcomes

Primary

Measure	Time frame
1.The study will evaluate the efficacy of the treatment through multiple assessment tools. 2.The investigator will measure the mean reduction in hyperpigmentation at baseline and after 4 weeks using the Investigator Global Assessment (IGA). 3.Photo damage will also be evaluated with IGA at both time points. 4.Crows feet wrinkles will be assessed using Bazins scale at baseline and week 4. 5.Skin quality will be assessed by both the investigator and the subject, focusing on radiance, smoothness, pigmentation, and other factors, with scores ranging from 1 to 10. 6.Skin brightness and wrinkle reduction will be measured using Cutometer and Chromameter or Mexameter at baseline, week 1, 2, and 4. 7.Global improvement will be evaluated by the subject and investigator through self-assessment and photographs. Based on primary outcomes, the treatment’s efficacy will be scored from 0 (no effect) to 4 (excellent effect). Timepoint: Visit 1 - Day 1 Visit 2 - Day 7 Visit 3 - Day 14 Visit 4 - Day 28	—

Measure

Time frame

1.The study will evaluate the efficacy of the treatment through multiple assessment tools. 2.The investigator will measure the mean reduction in hyperpigmentation at baseline and after 4 weeks using the Investigator Global Assessment (IGA). 3.Photo damage will also be evaluated with IGA at both time points. 4.Crows feet wrinkles will be assessed using Bazins scale at baseline and week 4. 5.Skin quality will be assessed by both the investigator and the subject, focusing on radiance, smoothness, pigmentation, and other factors, with scores ranging from 1 to 10. 6.Skin brightness and wrinkle reduction will be measured using Cutometer and Chromameter or Mexameter at baseline, week 1, 2, and 4. 7.Global improvement will be evaluated by the subject and investigator through self-assessment and photographs. Based on primary outcomes, the treatment’s efficacy will be scored from 0 (no effect) to 4 (excellent effect). Timepoint: Visit 1 - Day 1 Visit 2 - Day 7 Visit 3 - Day 14 Visit 4 - Day 28

—

Secondary

Measure	Time frame
To monitor for any adverse events during the study period and assess quality of life Timepoint: Visit 1 - Day 1 Visit 2 - Day 7 Visit 3 - Day 14 Visit 4 - Day 28	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

DK Elite Health Care Centre

roshanysakthibalan@gmail.com09943805988

Outcome results

None listed

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