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Skin Safety study on Healthy human subjects with sensitive skin

EVALUATION OF DERMATOLOGICAL SAFETY OF INVESTIGATIONAL PRODUCTS (06 BLEACH VARIANTS) BY SINGLE OPEN APPLICATION TEST ON ADULT HEALTHY INDIAN SUBJECTS WITH SENSITIVE SKIN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009741
Enrollment
24
Registered
2017-09-13
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: Product 1 (DRDC/2017/011): Oxylife Salon Professional Pure Oxygen Charcoal Detox Bleach Product 2 (DRDC/2017/012):: Oxylife Salon Professional Proyouth Anti Ageing Bleach Product 3(DRDC

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Healthy male and female subjects (in 1:1 ratio) in the age group of 18-55 years (both age inclusive) with sensitive skin 2 Subjects representing with normal, oily, dry and combination skin type in equal ratio 3 Subjects in good general health 4 Subjects with Fitzpatrick skin phototype III to V 5 Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire 6 Subjects who agree not to carry bleaching or any other procedures including waxing during the study period 7 Subjects able to read, understand and willing to give a voluntary written informed consent 8 Subjects willing to maintain the test patches in designated positions for a particular time duration 30 mins 9 Subjects not having participated in a similar or any other clinical trial in the past four weeks 10 Subjects willing to come for regular follow up visits 11 Subjects ready to follow instructions during the study period 12 Female subjects with child bearing potential willing to undergo Urine Pregnancy Test 13 Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results

Exclusion criteria

Exclusion criteria: 1 Subjects with known hypersensitivity to any of the study products or constituents 2 Subjects with any significant skin pathology in the investigational area 3 Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study 4 Subjects who are athletes and have a history of excessive sweating 5 Female subjects who are pregnant and lactating 5 Subjects with any significant medical condition that would interfere with the participation in the trial

Design outcomes

Primary

MeasureTime frame
Evaluation of Dermatological safety of investigational products (06 bleaching cream variants) by single open application test on adult healthy Indian subjects with sensitive skinTimepoint: 0 hr, 24 hr, 48 hr & 7 days

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

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