Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506482015278 Date of Registration: 19/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A safety study of two herbal ointment for the treatment of Ringworm.
Official scientific title A phase-I clinical investigation to the safety of two herbal ointment formulations for an intended treatment of Tinea corporis/cruris (ClinHerb1)
Brief summary describing the background and objectives of the trial Dermatophytosis is a common contagious disease of the skin caused by fungi known as dermatophytes. It is caused by pathogenic, keratin-digesting fungi in the genera Microsporum, Trichophyton and Epidermophyton. A prevalence study conducted in Ethiopia showed that there is a high dermatophytosis. Among the clinical manifestations of the superficial fungal infections, Tinea capitis (28%), Tinea corporis (17.3%), and Tinea unguium (3.5%) represented in the majority of the dermatophytosis cases. The trends for emerging antimicrobial resistance demand for a continuous innovation to safe and efficacious medication. Dermatological formulations based on safe and effective medicinal herbs originated from indigenous knowledge and practice therefore could be considered in clinical developments as alternate option. Use of medicinal plants for therapeutic purpose following clinical evaluation have advantages from the point of view affordability, accessibility of raw materials, enhancing local manufacturing capacity and income, opportunity for job creation, innovation and national self-reliance Based on the promising effect of the pre-clinical study and ethnomedicinal information of the medicinal herb’s topical anti-fungal formulations, this study is therefore intended to evaluate the safety of the antifungal herbal formulations in human study participants which will be followed by subsequent trials to ensure the potentials of medicinal herbs formulation for the management of dermatophytosis. The primary objective is to assess the safety of herbal ointment formulations, IMP1 and IMP2, to their therapeutically proposed dose strength on healthy human skin.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ClinHerb1
Disease(s) or condition(s) being studied Healthy participants
Sub-Disease(s) or condition(s) being studied
Purpose of the trial to evaluate safety of essential oils.
Anticipated trial start date 23/06/2025
Actual trial start date
Anticipated date of last follow up 05/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IMP 1 and 2 A single Patch test followed by twice daily for Repeat Open Application Test (ROAT) Single patch test is followed on days 2, 4 and 7, ROAT is done and followed for 07 days. IMPs 1 and 2 are applied on human skin of healthy participants to evaluate safety of the essential oils. each are will enroll 15 participants. 15
Control Group Vehicle similar to the experimental arm similar to the experimental arms Base for the formulation of essential oils is applied on the contralateral side of the IMPs site and used as a comparator.. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Healthy male and/or female subjects of age 18+years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination & clinical laboratory tests. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures 1. Evidence or history of clinically significant abnormalities 2. Subjects with any active skin condition at the application site that can possibly affecting drug absorption. 3. Subjects with a skin condition (Draize) score >0 of the test area immediately prior to first treatment application. 4. Subjects using topical prescriptions or non-prescription drugs within 14 days of the first treatment application. 5. Subjects not willing to avoid application of treatments such as lotions or creams on the application site throughout the study follow-up. 6. Pregnant and lactating woman Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2025 AHRIALERT ERC
Ethics Committee Address
Street address City Postal code Country
ALERT Compound Jima Road Addis Ababa 1005 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of serious adverse drug reaction(s) in comparison to placebo/vehicle for single patch test and for repeated open application tests At its occurrence
Secondary Outcome 1. Changes from baseline vital signs (blood pressure, pulse rate, body temp & respiratory rate) 2. Incidence and severity of treatment emergent adverse events 3. Incidence and magnitude of treatment emergent laboratory abnormalities 4. Changes from baseline on skin irritation assessment scores after treatment at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Armauer Hansen Research Center Alert Compound, Jima Road Addis Ababa 1005 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Armauer Hansen Research Institute Jima Road Addis Ababa 1005 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Armauer Hansen Research Institute Jima Road Addis Ababa 1005 Ethiopia Research Center
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adamu Bayissa Kiltu adamu.bayissa@ahri.gov.et +251929041898 Jima Road
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Senior Researcher
Role Name Email Phone Street address
Public Enquiries Frehiwot Teka Frehiwot.Teka@ahri.gov.et +251911638114 Jima Road
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Mekonnen Tferi Mekonnen mekonnen.teferi@ahri.gov.et +251911103233 Jema Road
City Postal code Country Position/Affiliation
Addis Ababa 1005 Ethiopia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will collected safeguarding the confidentiality of study participants, dataset will be anonymized before analysis. As this is an early phase clinical trial evaluating safety, secondary analysis is not feasible. However, dataset will be shared on request. Clinical Study Report After study completion signing confidentiality agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 08/06/2025 Added A safety study of herbal ointment for the treatment of Ringworm.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 08/06/2025 Public tittle added A safety study of herbal ointment for the treatment of Ringworm. A safety study of two herbal ointment for the treatment of Ringworm.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/06/2025 Just to respond to admin (system) queries. However the participants will be randomized to the IMPs (IMP1 and IMP2) thus all who applied the IMPs will also apply the Control arm on the contralateral side of the body. Control Group, Vehicle, similar to the experimental arm, similar to the experimental arms, Base for the formulation of essential oils is applied on the contralateral side of the IMPs site and used as a comparator.., 15, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 08/06/2025 The group sample size for IMPs 1 and 2 is 30 (15 per each IMP) Experimental Group, IMP 1 and 2, A single Patch test followed by twice daily for Repeat Open Application Test (ROAT), Single patch test is followed on days 2, 4 and 7, ROAT is done and followed for 07 days. , IMPs 1 and 2 are applied on human skin of healthy participants to evaluate safety of the essential oils. each are will enroll 15 participants., 15, Experimental Group, IMP 1 and 2, A single Patch test followed by twice daily for Repeat Open Application Test (ROAT), Single patch test is followed on days 2, 4 and 7, ROAT is done and followed for 07 days. , IMPs 1 and 2 are applied on human skin of healthy participants to evaluate safety of the essential oils. each are will enroll 15 participants., 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/06/2025 Just to respond to admin (system) queries. However the participants will be randomized to the IMPs (IMP1 and IMP2) thus all who applied the IMPs will also apply the Control arm on the contralateral side of the body. Experimental Group, IMP 1 and 2, A single Patch test followed by twice daily for Repeat Open Application Test (ROAT), Single patch test is followed on days 2, 4 and 7, ROAT is done and followed for 07 days. , IMPs 1 and 2 are applied on human skin of healthy participants to evaluate safety of the essential oils. each are will enroll 15 participants., 30, Experimental Group, IMP 1 and 2, A single Patch test followed by twice daily for Repeat Open Application Test (ROAT), Single patch test is followed on days 2, 4 and 7, ROAT is done and followed for 07 days. , IMPs 1 and 2 are applied on human skin of healthy participants to evaluate safety of the essential oils. each are will enroll 15 participants., 15,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2025 PACTR Admin TRUE, AHRALERT ERC, ALERT Compound Jima Road, Addis Ababa, 1005, Ethiopia, , 21 Mar 2025, +251113483752, ahri.alerterc@ahri.gov.et, 34803_31956_4737.pdf TRUE, AHRIALERT ERC, ALERT Compound Jima Road, Addis Ababa, 1005, Ethiopia, , 21 Mar 2025, +251113483752, ahri.alerterc@ahri.gov.et, 34803_31956_4737.pdf