Clinical Study on hair dye and hair dye shampoo in grey hair of healthy participants

Evaluation of Dyeing Efficacy of hair dye and hair dye shampoo in grey hair of Healthy Volunteers – A open label, prospective, interventional clinical study - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097433

Enrollment

Registered

2025-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

None listed

Interventions

Intervention1: Hair Dye Cream and Hair Colour/ Dye Shampoo: 18 subjects from Cohort 1 will be instructed for single application of hair dye cream while remaining 18 subjects will be asked to reapply h

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and females with visible grey hair greater than or equal to 30 percent 2. Willingness to use only assigned product during study. 3. No active scalp disease or severe dermatological condition. 4. Subjects who are willing to give informed consent and ready to comply with the protocol

Exclusion criteria

Exclusion criteria: 1. Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation 2. Subjects who have used hair dye products over the last 2 months. 3. Known cases of Hypersensitivity to any ingredient of dye. 4. History of severe allergic scalp reactions. 5. Recent use of systemic corticosteroids or immunosuppressants. 6. Pregnant or lactating women. 7. Subjects who have participated in any other clinical study since last 3 months 8. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.

Design outcomes

Primary

Measure	Time frame
1.Colour coverage (grey hair coverage, uniformity, intensity) 2.Time (mins) taken by hair dye and hair colour shampoo to colour coverage (grey hair coverage, uniformity, intensity) immediately post application. Timepoint: Screening Baseline Visit (Day 0), Follow up Visit 1 Day 1 (24 hrs. post skin patch test application, visit 2 (48 hrs. post skin patch test application, Follow Up Visit 3 (Week 2), Follow Up Visit 4 (Week 4), Follow Up Visit 5 (Week 5), Follow Up Visit 6 (Week 6)	—

Measure

Time frame

1.Colour coverage (grey hair coverage, uniformity, intensity) 2.Time (mins) taken by hair dye and hair colour shampoo to colour coverage (grey hair coverage, uniformity, intensity) immediately post application. Timepoint: Screening Baseline Visit (Day 0), Follow up Visit 1 Day 1 (24 hrs. post skin patch test application, visit 2 (48 hrs. post skin patch test application, Follow Up Visit 3 (Week 2), Follow Up Visit 4 (Week 4), Follow Up Visit 5 (Week 5), Follow Up Visit 6 (Week 6)

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Secondary

Measure	Time frame
1. Skin patch test using Dermal Response Score. 2. Tolerability (scalp irritation, allergic response, dermatological adverse events) of hair dye and hair dye shampoo. 3. Requirement of reapplication of hair dye and hair colour shampoo (number of days) and assessment of hair damage (thinning, breakage fall, roughness, dryness -yes or no) due to repeated application of hair dye and hair colour shampoo 4. Color retention or fading 5. Hair quality (shine or gloss, texture or smoothness, hair breakage or dryness) 6. User satisfaction and convenience (ease of use, odour, staining, wash-off) 7. Global assessment of overall change by investigator and subjects 8. Tolerability of study products by investigator and subjects 9. Adverse events and adverse drug reaction including vitalsTimepoint: Screening Baseline Visit (Day 0), Follow up Visit 1 Day 1 (24 hrs. post skin patch test application, visit 2 (48 hrs. post skin patch test application, Follow Up Visit 3 (Week 2), Follow Up Visit 4 (Week 4), Follow Up Visit 5 (Week 5), Follow Up Visit 6 (Week 6)	—

Measure

Time frame

1. Skin patch test using Dermal Response Score. 2. Tolerability (scalp irritation, allergic response, dermatological adverse events) of hair dye and hair dye shampoo. 3. Requirement of reapplication of hair dye and hair colour shampoo (number of days) and assessment of hair damage (thinning, breakage fall, roughness, dryness -yes or no) due to repeated application of hair dye and hair colour shampoo 4. Color retention or fading 5. Hair quality (shine or gloss, texture or smoothness, hair breakage or dryness) 6. User satisfaction and convenience (ease of use, odour, staining, wash-off) 7. Global assessment of overall change by investigator and subjects 8. Tolerability of study products by investigator and subjects 9. Adverse events and adverse drug reaction including vitalsTimepoint: Screening Baseline Visit (Day 0), Follow up Visit 1 Day 1 (24 hrs. post skin patch test application, visit 2 (48 hrs. post skin patch test application, Follow Up Visit 3 (Week 2), Follow Up Visit 4 (Week 4), Follow Up Visit 5 (Week 5), Follow Up Visit 6 (Week 6)

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results