Home » Trials » SLCTR/2026/023
Safety and Efficacy of Glomix Skin Conditioner in Healthy Adult Volunteers at the Faculty of Allied Health Sciences, University of Ruhuna: Phase 1 and Phase 11 Clinical Trial
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SLCTR Registration Number
SLCTR/2026/023
Date of Registration
The date of last modification
Sep 05, 2026
Scientific Title of Trial
Safety and Efficacy of Glomix Skin Conditioner in Healthy Adult Volunteers at the Faculty of Allied Health Sciences, University of Ruhuna: Phase 1 and Phase 11 Clinical Trial
Public Title of Trial
A Phase I Controlled and Phase II Single-Arm Study Evaluating the Safety, Hydration, and Brightening Efficacy of Glomix Skin Conditioner in Healthy Adult Volunteers at the University of Ruhuna
Disease or Health Condition(s) Studied
Skin hydration and brightness/tone
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1337-9395
Any other number(s) assigned to the trial and issuing authority
2025/P/090 (Faculty of Medicine, Ruhuna))
What is the research question being addressed?
Is the Glomix Skin Conditioner safe for use on the skin of healthy adults compared to a non-medicated cream base (without actives), and how effectively does it improve skin hydration and brightness/tone compared to baseline (pre-treatment) measurements?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Other
Study Phase
Phase 1-2
Intervention(s) planned
Two types of patches will be used: - Medicated Patch: Contains the Glomix Skin Conditioner - Non-medicated Patch: Contains the cream base (without actives)
The Phase I study will be conducted in three key phases: Induction, Rest, and Challenge, followed by final assessment (This is the gold standard procedure for Repeat Insult Patch Test;RIPT ).
Each patch (medicated and non-medicated) will be applied simultaneously on different marked sites, typically on the upper medial side of the arm of the participant, with clear labeling that only can be identified by the patch applying investigator. • Patches are semi-occlusive and kept in place for 24 hours • After removal, the site is evaluated before the next application
After the induction phase, there will be a rest period of 10–14 days during which no patches or products will be applied to the test area.
The patch will be removed after 24 hours, and the test site will be evaluated for skin reactions at 24-, 48-, and 72-hour post-application.
Phase II: - On Day 0, participants will undergo baseline evaluation at the designated application site (e.g., volar upper medial side of the arm. Participants will apply Glomix Skin Conditioner twice daily (morning and evening) to the target area for 42 days (6 weeks). Follow-up visits will occur on Day 7, Day 14, Day 28, and Day 42, and the skin condition will be assessed.
Inclusion criteria
Phase I: - • Healthy adults (males and females) aged over 20 years. • Participants with Fitzpatrick skin types I–IV, which represent a range of skin tones from light to medium brown. • No history of chronic skin conditions such as eczema, psoriasis, or rosacea.
Phase II:- • Adults aged between 20 to 60 years. • Participants who have completed the RIPT procedure without developing any sensitization or • adverse skin reactions. • Participants with Fitzpatrick skin types I–IV. • No underlying chronic dermatological conditions. • Willingness to comply with the study protocol and attend all follow-up visits.
Exclusion criteria
Phase I: - • History of atopic dermatitis or other chronic skin disorders. • Current use of immunosuppressive medications or treatments that could affect skin reactivity. • Known sensitivity or allergy to any of the ingredients in the Glomix Skin Conditioner.
Phase II:- • Participants who exhibit any positive reaction (e.g., +, ++, +++) during the RIPT, indicating • potential skin sensitization or intolerance to the product. • History of atopic dermatitis, psoriasis, or other chronic skin conditions. • Use of immunosuppressive medications or treatments that could affect skin reactivity. • Known sensitivity or allergy to any of the ingredients in the Glomix Skin Conditioner. • Participation in another clinical trial within the last 30 days.
Primary outcome(s)
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1.
PHASE I During the Induction Phase, - Primary Outcome Measure: Mean Cumulative Irritation Index (MCII) Metric / Method of Measurement: Skin reactions (erythema, oedema, dryness, and vesicles) will be graded on a standardized 0–3 numerical scale (where 0 = absent and 3 = severe). In the Challenge Phase, - Primary Outcome Measure: Skin Sensitization Potential (Allergic Contact Dermatitis) Metric / Method of Measurement: The skin reaction at the challenge site will be graded using the International Contact Dermatitis Research Group (ICDRG) criteria. PHASE II Primary Outcome Measure: This phase will assess whether the test product improves skin hydration, brightness, and tone over six weeks. Skin hydration will be measured by gently placing a Corneometer on the upper inner arm at five points and recording the average reading. Skin colour will be measured using a colorimeter at four points, assessing brightness, colour intensity, and tone. Measurements will be taken under controlled conditions before treatment and at weeks 3 and 6, with the same trained investigator performing all tests. Surrounding normal skin will also be measured for comparison. Subjective skin condition scoring (via participant questionnaire) Clinical observation for dryness, flakiness, or discoloration |
[ • Primary Outcome 1: Mean Cumulative Irritation Index. o Time of Assessment: 3 times per week for 3 weeks (Induction Phase). • Primary Outcome 2: Skin Sensitization Potential. o Time of Assessment: At 24, 48, and 72 hours following patch removal. PHASE II On Day 0, Day 7, Day 14, Day 28, and Day 42 ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
PHASE I - 80, PHASE II - 40, TOTAL = 120
Countries of recruitment
Sri Lanka
Anticipated start date
2026-09-05
Anticipated end date
2027-02-28
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
This study is funded by the Technology Transfer Office (TTO), University of Ruhuna, and FADNA Life Science Pvt Ltd
Regulatory approvals
Sub-Committee on Clinical Trials, Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2026-03-06
Approval number
2025/P/090(27.08.2025)
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Ruhuna. |
| Institutional Address: | Faculty of Medicine, University of Ruhuna. |
| Telephone: | +094-091-2232288 |
| Email: | ethics@med.ruh.ac.Ik |
Contact person for Scientific Queries/Principal Investigator
Dr. L.B.L. Prabodha
Senior Lecturer
Department of Anatomy, Faculty of
Medicine, University of Ruhuna
+94912234801/3 Ext 178
+94777365212/ +94715591091
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lahiruprabodha@gmail.com
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Contact Person for Public Queries
Dr. L.B.L. Prabodha
Senior Lecturer
Department of Anatomy, Faculty of
Medicine, University of Ruhuna
+94912234801/3 Ext 178
+94777365212/ +94715591091
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lahiruprabodha@gmail.com
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Primary study sponsor/organization
Technology Transfer Office (TTO), University of Ruhuna
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Technology Transfer Office,
University of Ruhuna,
Matara,
Sri Lanka.
+094412222681-2 - Ext 2183
techtransferoffice.ruh@gmail.com
https://www.tto.ruh.ac.lk
Secondary study sponsor (If any)
FADNA Life Science pvt Ltd
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Fadna Tea Pvt. Ltd.
No 106/6A, Araliya Uyana, Pannipitiya
+94 77 98 74 777
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mail@fadna.com
https://fadna.com/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results reported in the publication (including text, tables, figures, and appendices) will be made available after formal de-identification. Additional documents, including the study protocol and statistical analysis plan, will also be accessible. This data will be available beginning 3 months and ending 5 years following official article publication. Access will be granted to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, specifically to achieve the specific research aims outlined in an approved academic proposal or for individual participant data meta-analysis. Proposals regarding data access should be directed to lahiruprabodha@gmail.com, and data requestors will be required to sign a formal data access agreement to secure access.
Study protocol available
Yes
Protocol version and date
Version 1.2, 10.11.2025
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
