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Clinical trial on detergents in healthy human volunteers

A Randomized, Double blinded, Comparative study to evaluate the efficacy of dermal irritancy potential of detergents in healthy human volunteers. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055614
Enrollment
24
Registered
2023-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

None listed

Interventions

Intervention1: India SFXL QW detergent powder 1: Dose:3grams/l dissolved in hard water 24 French Hardness for hand immersion. Duration: 3 Days Control Intervention1: India SFXL QW detergent powder 2:

Sponsors

Unilever Industries Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult volunteers between 18 and 45 years. 2. Photo type II to V (which includes sensitive skin type) 3. Having apparently healthy skin on test area. 4. No H O any allergies to any food/ food ingredients. 5. For whom the investigator considers that the compliance will be correct. 6. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures. 7. Having signed a Consent Form. 8. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 9. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study. 10. hould avoid using any type of moisturizing cream or soaps or face wash during the study (14days). 11. Should be able to read and write (in English, Hindi or local language). 12. Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: 1. Pregnant/nursing mothers 2. Scars, excessive terminal hair or tattoo on the studied area. 3. Dermatological infection/pathology on the level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). 5. Any allergies to any food/ food ingredients 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 7. Chronic illness which may influence the outcome of the study. 8. Using any type of Moisturizing cream or soaps or face wash. 9. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 10. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
1. Comparison of Skin reaction scores (dryness & scales) between comparator & test products. 2. Comparison of Videoscopy between comparator & test products. 3. Comparison of pH level between comparator and test products. 4. Comparison of TEWL between comparator and test products. 5. Comparison of Hydration level between comparator and test products Timepoint: Day 0 to Day 7

Secondary

MeasureTime frame
Incidence & rate of adverse events.Timepoint: Day 0 o Day 7

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant research services pvt. Ltd

surya.ashok@gmail.com9880999297

Outcome results

None listed

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