A Phase IV, randomized, single-blinded study to evaluate the efficacy and safety of ketoconazole 2% shampoo + conditioner vs ketoconazole 2% shampoo alone in adults with seborrheic dermatitis
Seborrheic dermatitis (SD)
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 either Ketoconazole 2% Shampoo plus Conditioner or Ketoconazole 2% Shampoo alone. The randomization schedule will be generated by CIDP’s biostatistician by using SAS® statistical software (Version: 9.4 or higher; 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 compliance to the randomization schedule. All other staff will not have access to the randomization schedule during the course of analysis in order to minimize/ avoid bias. Apart from the personnel involved in the dispensing of IP all other staff (incl. the investigators) will be blinded and participants will be instructed not to disclose their treatment (shampoo only or shampoo + conditioner). Arm 1 (Test): Ketoconazole 2% Shampoo (Terzolin® 2% Solution) + Terzolin® Expert Conditioner (Nizoral Anti-Dandruff Daily Prevent Conditioner in UK market). Arm 2 (Comparator): Ketoconazole 2% Shampoo (Terzolin® 2% Solution) alone Products will be used twice per week for 28 days. Each participant will attend five visits at the study site (on days 0, 7, 14, 21, and 28). Doctors will assess hair hydration, hair texture, scalp condition, and symptoms. Participants will also complete questionnaires on quality of life, symptoms, and satisfaction with the products.
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
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