Ozonated Oil Emulsion for Seborrhea in Women

NCT07559617 | Completed

• 2 other identifiers: SHAMNA-2024-008SSS-008-2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a new ozonated oil-based hair cream for women with oily scalp (seborrhea). The cream contains natural oils (moringa, wheat germ, olive, and chili extract) treated with ozone, plus biotin (vitamin B7). 66 women aged 18-40 years participated in this 6-week study. Participants were randomly assigned to receive either:

• The active cream (ozonated oils + biotin), OR
• A placebo cream (without active ingredients) Neither the participants nor the researchers knew which cream was given (double-blind). Participants applied the cream to their scalp every evening for 6 weeks. The main goal was to measure changes in scalp oil (sebum) production at Week 6 compared to baseline. Other outcomes included hair manageability, shine, and scalp comfort. Results showed that the active cream significantly reduced scalp oil by 28% compared to 10% in the placebo group. The cream was well-tolerated with only mild side effects (scalp irritation in 6% of active group). This study suggests that ozonated oil emulsion may be a safe and effective cosmetic option for managing oily scalp in women.

Conditions

Cosmetic Management of Oily Scalp

Keywords

Ozonated oils; Biotin; Oily scalp; Seborrhea; Cosmetic dermatology; Sebum reduction

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in scalp sebum content measured by Sebumeter

  Objective measurement of scalp sebum production using Sebumeter SM 815 (Courage+Khazaka, Germany). Three standardized sites (vertex, left and right parietal regions) measured and averaged. Negative values indicate sebum reduction. Pre-specified clinically meaningful threshold: 15% absolute reduction.

  Baseline (Day 0) and Week 6

Secondary Outcomes (3)

• Hair shine score (investigator-rated)

  Baseline, Week 2, Week 4, Week 6

• Scalp comfort score (participant-reported)

  Baseline, Week 2, Week 4, Week 6

• Investigator Global Assessment success rate

  Week 6

Other Outcomes (4)

• Adverse event rate

  Throughout 6-week study period

• Scalp irritation score

  Week 2, Week 4, Week 6

• Product adherence percentage

  Throughout 6-week study period

Study Arms (2)

Ozonated oil-based cosmetic emulsion

EXPERIMENTAL

Low oil-in-water emulsion containing ozonated natural oils (Moringa oleifera, Triticum vulgare, Olea europaea, Capsicum annuum oleoresin) plus biotin 0.1%. Applied 5g to scalp evening, overnight, rinsed morning for 6 weeks.

Other: Ozonated oil-based cosmetic emulsion

Matched vehicle control

OTHER

Identical base formulation with caprylic/capric triglyceride and isopropyl palmitate to match total oil phase (8%), rheology, and cosmetic elegance. Same application protocol: 5g evening, overnight, 6 weeks.

Other: Matched vehicle control

Interventions

Ozonated oil-based cosmetic emulsion OTHER

Low oil-in-water emulsion containing ozonated natural oils (Moringa oleifera 3%, Triticum vulgare 1.95%, Olea europaea 2%, Capsicum annuum oleoresin 0.05%) plus biotin 0.1%. Applied 5g to scalp evening, overnight, rinsed morning for 6 weeks.

Also known as: Ozonated Oil Emulsion

Ozonated oil-based cosmetic emulsion

Matched vehicle control OTHER

Identical base formulation with caprylic/capric triglyceride 6% and isopropyl palmitate 2% to match total oil phase (8%), rheology, and cosmetic elegance. Same application protocol: 5g evening, overnight, 6 weeks.

Also known as: Vehicle Control

Matched vehicle control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female sex (biological), ages 18-40 years
• Objective sebum measurement ≥200 µg/cm² at baseline (Sebumeter SM 815)
• Self-reported daily or near-daily hair washing due to oily scalp
• Willing to abstain from other hair treatments for 2-week washout and study duration
• Signed informed consent

You may not qualify if:

• Active scalp dermatoses (psoriasis, atopic dermatitis, tinea capitis) requiring medical treatment
• Known hypersensitivity to study ingredients or fragrance components
• Pregnancy, lactation, or planned pregnancy during study period
• Systemic medications affecting sebum production (isotretinoin, hormonal contraceptives initiated within 3 months, anti-androgens)
• Participation in other cosmetic or pharmaceutical trials within 30 days

Sponsors & Collaborators

• Chadi Khatib: lead

Study Sites (1)

Clinical Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo

Aleppo, Syria

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Hisham M Kasem, Prof.

  Syrian Scientific Society for Medicinal Herbs

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind design: participants, investigators, study staff, and statisticians remained masked to treatment assignment throughout the trial. Product identity concealed via identical packaging, appearance, texture, and fragrance-masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, randomized, placebo-controlled, parallel-group trial with 1:1 allocation ratio and stratification by baseline sebum severity

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 30, 2026
• Study Start: April 6, 2024
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Start Date: Within 6 months of publication End Date: Permanent availability with DOI
• Access Criteria: Who: Qualified researchers with methodologically sound proposals What: De-identified participant data (CSV), statistical analysis plan (PDF), study protocol (PDF), and analytic code (SAS/R scripts) How: Submit request via repository platform with brief research proposal. Data use agreement required. Contact corresponding author for access procedures.

Locations

SY (1)