Seborrheic dermatitis (SD) Skin and Connective Tissue Diseases
Conditions
Interventions
The order of receiving the investigational product for each participant will be determined according to a randomization schedule. Participants will be randomized to one of the two groups to receive ei
SAS Institute Inc., USA).
The randomization schedule will be maintained under controlled access. The personnel involved in the dispensing of investigational products will be accountable for ensuring
Sponsors
STADA Arzneimittel AG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18-65 years 2. Participants presenting a minimum hair length of 5 cm and agreeing to this criterion during the entire study period 3. Participants with mild to severe Seborrheic Dermatitis on the scalp 4. Participants presenting with all scalp types 5. Participants presenting with all hair type 6. Non-pregnant and non-breastfeeding participants 7. Participants having received the information about the study modalities and having given his/her written consent and having signed the informed consent form specific for this study, in accordance with the corresponding procedure 8. Participants usual users of shampoo two times a week and accepting to follow a rate of two times a week during the whole study period 9. Participantls agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular: 9.1. Three days before the study visit, no styling products (e.g. tonic, spray, lotion, foam, gel, wax, etc) 9.2. No treating haircare products (conditioner, hair mask, non-rinsed hair care product, oil) 9.3. No anti-scales products (whatever the type: shampoo, treatment); no hair colouring or hair bleaching within one week prior to any study visit 10. Participants in good general and mental health in the opinion of the investigator 11. Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form 12. Participants who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
Exclusion criteria
Exclusion criteria: 1. Participants should not use of any anti-dandruff/SD/conditioning products (containing ketoconazole, selenium sulphide, coal tar etc) or any topical treatment (anti-fungals, corticosteroids, calcineurin inhibitors and salicylic acid) 2 weeks before the study. 2. Participants presenting with scalp psoriasis. 3. Participants suffering from any other scalp disorders e.g. bacterial folliculitis, tinea capitis, alopecia areata 4. Participants who have used topic treatment for the scalp (anti-hair loss, soothing) during the last 3 weeks before the start of the study. 5. Participants who have used products for the scalp (dyeing, bleaching, permanent waving and straightening) within the 3 weeks prior to the study 6. Participants with sensitivity and allergy to ketoconazole or other component 7. Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles 8. History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment 9. Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study 10. Participants with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner) 11. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol 12. Clinical signs and/or history of immunosuppression 13. Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris 14. Treatment with any other investigational drug in the 4 weeks prior to study entry 15. Employee of the sponsor or the study site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Hair hydration measured by dermatologist Visual Analogue Scale (VAS), gravimetric hair measurements, and participant self-evaluation from baseline (Day 0) to Day 28 2. Hair texture measured by dermatologist Visual Analogue Scale (VAS) and participant self-evaluation. from baseline (Day 0) to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seborrheic dermatitis symptoms from baseline to Day 28, measured by: 1.1. Symptoms Scale of Seborrheic Dermatitis (SSSD) at Days 0, 14, and 28 1.2. Total Scale Scores (TSS) at Days 0, 14, and 28 2. Pruritus severity measured using Numeric Rating Scale (NRS, 0–10) at Days 0, 14, and 28 3. Erythema measured using Visual Analogue Scale (VAS, 0–10) at Days 0, 14, and 28 4. Scalp greasiness measured using Visual Analogue Scale (VAS, 0–10) at Days 0, 14, and 28 5. Scalp hydration measured by Corneometer® readings at Days 0, 7, 14, 21, and 28 6. Quality of life measured by Scalpdex questionnaire at Days 0, 14, and 28 7. Cosmetic acceptability of products assessed by participant self-evaluation questionnaires (cosmeticity, acceptability, efficacy, global satisfaction) at Days 14 and 28 8. Safety and tolerance of products assessed by incidence of local intolerances and adverse events throughout the study (Day 0–28) | — |
Countries
Mauritius
Contacts
Public ContactVimi Kolanthan
Outcome results
None listed